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Childrens Ibuprofen 572

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Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 100 mg/5 mL
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 3, 2025
Manufacturer
Family Dollar Services, Inc.
Registration number
ANDA210149
NDC root
55319-929
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Children's Ibuprofen is an oral suspension medication designed for children aged 2 to 11 years. It serves as a pain reliever and fever reducer, helping to alleviate minor aches and pains associated with common conditions like the cold, flu, sore throat, headache, and toothache. This medication is alcohol-free and comes in a pleasant bubble gum flavor, making it easier for children to take.

As a nonsteroidal anti-inflammatory drug (NSAID), Children's Ibuprofen works by reducing inflammation and lowering fever, providing relief for up to eight hours. It is comparable to the active ingredient found in Children's Motrin, offering a trusted option for parents seeking to manage their child's discomfort.

Uses

You can use this medication to help relieve minor aches and pains caused by common conditions like the cold, flu, sore throat, headache, and toothache. It’s also effective in reducing fever, making it a helpful option when you're feeling unwell.

Rest assured, this medication does not have any teratogenic effects, meaning it does not cause birth defects. This makes it a safer choice for those who may be concerned about such risks.

Dosage and Administration

Before using this product, it's important to note that it does not come with specific directions or warnings for adults. Always make sure to follow the recommended dosage and never exceed the amount directed. To prepare the medication, shake the bottle well before use.

To find the right dose, refer to the dosing chart provided. If possible, use your child's weight to determine the dosage; if not, you can use their age. Make sure to use only the enclosed dosing cup for measuring, as other devices may not provide accurate measurements. Depending on your child's needs, you can repeat the dose every 6 to 8 hours, but do not administer it more than four times a day. Here’s a quick reference for dosing based on weight and age:

  • For children under 2 years or weighing less than 24 pounds, consult a doctor for the appropriate dose.

  • For children aged 2 to 3 years and weighing between 24 to 35 pounds, the dose is 5 mL.

  • For ages 4 to 5 years and weighing 36 to 47 pounds, the dose is 7.5 mL.

  • For ages 6 to 8 years and weighing 48 to 59 pounds, the dose is 10 mL.

  • For ages 9 to 10 years and weighing 60 to 71 pounds, the dose is 12.5 mL.

  • For children aged 11 years and weighing 72 to 95 pounds, the dose is 15 mL.

Always consult with a doctor if you have any questions or concerns about the dosage.

What to Avoid

You should avoid using this medication if your child has ever had an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious risks.

Be cautious about the dosage; using more than directed or for longer than recommended can increase the risk of heart attack or stroke. Always follow the instructions carefully to ensure your child's safety.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, wheezing (asthma), skin reddening, facial swelling, shock, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially if your child has a history of stomach ulcers, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen.

If your child experiences any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, you should seek medical attention immediately. It's also important to consult a doctor if your child has a severe sore throat with high fever, headache, nausea, or vomiting, or if symptoms worsen or persist beyond a few days. Always talk to a healthcare professional before using ibuprofen if your child has any underlying health issues or is taking other medications.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, wheezing, skin reddening, facial swelling, shock, rash, or blisters. If you notice any of these signs, stop using the medication and seek medical help immediately.

This medication can also lead to severe stomach bleeding, particularly if your child has a history of stomach ulcers or bleeding issues, is taking blood thinners or steroids, or is using other NSAIDs (nonsteroidal anti-inflammatory drugs) like aspirin or naproxen. Be cautious and do not use ibuprofen for more than two days for a sore throat, especially in children under three, unless directed by a doctor.

If you suspect an overdose, contact a Poison Control Center or seek emergency medical help right away. Additionally, stop using ibuprofen and call your doctor if your child experiences symptoms like faintness, vomiting blood, bloody or black stools, persistent stomach pain, or if fever or pain worsens or lasts more than three days. Always consult your doctor if new symptoms arise or if relief is not achieved within the first 24 hours of treatment.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications. The information provided does not specify any safety concerns, dosage changes, or special precautions for using ibuprofen during pregnancy. This means that there is no clear guidance on its use in this situation.

Before taking ibuprofen or any medication while pregnant, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your individual circumstances. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

When considering this medication for your child, it's important to follow specific age and weight guidelines for dosing. For children under 2 years old who weigh less than 24 lbs, you should consult a doctor before use. For those aged 2 to 3 years and weighing between 24-35 lbs, the recommended dose is 5 mL. As your child grows, the dosage increases: 7.5 mL for ages 4-5 years (36-47 lbs), 10 mL for ages 6-8 years (48-59 lbs), 12.5 mL for ages 9-10 years (60-71 lbs), and 15 mL for 11-year-olds (72-95 lbs).

It's crucial to be aware of safety concerns. Avoid using this medication in children under 3 years unless directed by a doctor. Always consult a healthcare professional if your child has a history of stomach issues, high blood pressure, heart disease, liver or kidney problems, asthma, or if they are taking certain other medications. Additionally, seek medical advice if your child experiences severe sore throat symptoms, especially if accompanied by high fever or other serious signs, or if there are concerns about stomach bleeding.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Make sure to keep your doctor informed about any liver issues you may have, as they may want to monitor your health closely while you are on medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its quality. It's also crucial to check the packaging before use: do not use the product if the carton is opened or if the printed inner seal marked "SEALED for YOUR PROTECTION" is broken or missing. This seal is an important indicator that the product has not been tampered with and is safe for use.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should take this medication orally, and if necessary, you can repeat the dose every 6 to 8 hours. However, do not exceed four doses in a single day. If you experience stomach upset, it's advisable to take the medication with food or milk.

In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

FAQ

What is Children's Ibuprofen?

Children's Ibuprofen is an oral suspension pain reliever and fever reducer, available in a bubble gum flavor, intended for children aged 2 to 11 years.

What does Children's Ibuprofen treat?

It relieves minor aches and pains due to the common cold, flu, sore throat, headache, and toothache, and it also reduces fever.

How should I dose Children's Ibuprofen?

Use the enclosed dosing cup and refer to the dosing chart based on your child's weight or age. Do not exceed 4 doses in a day.

What should I do if my child has a history of stomach problems?

Consult a doctor before using Children's Ibuprofen if your child has a history of stomach problems, such as heartburn or ulcers.

Are there any serious side effects to watch for?

Yes, watch for signs of stomach bleeding, such as vomiting blood or having black stools, and seek medical help if these occur.

Can I give Children's Ibuprofen to a child under 2 years?

You should ask a doctor before giving Children's Ibuprofen to a child under 2 years or weighing less than 24 lbs.

What should I do if my child experiences an allergic reaction?

If your child shows signs of a severe allergic reaction, such as hives or difficulty breathing, stop use immediately and seek medical help.

How should I store Children's Ibuprofen?

Store Children's Ibuprofen between 20-25°C (68-77°F) and do not use it if the carton is opened or the inner seal is broken.

Is it safe to use Children's Ibuprofen during pregnancy?

There is no specific information provided regarding the use of Children's Ibuprofen during pregnancy.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

Below are the non-prescription pack sizes of Childrens Ibuprofen 572 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen 572.
Details

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen 572, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of minor aches and pains associated with the common cold, influenza, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup must be utilized for accurate measurement; no other dosing devices should be employed.

The recommended dosing intervals are every 6 to 8 hours as needed, with a maximum of four doses per day. The following dosing chart provides specific guidance:

  • For patients weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

  • For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

  • For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

  • For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

  • For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

  • For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Healthcare professionals should ensure that patients do not exceed the maximum recommended doses and should advise caregivers to seek medical guidance if there are any uncertainties regarding dosing.

Contraindications

Use of this product is contraindicated in the following situations:

  • In patients with a history of allergic reactions to ibuprofen or any other pain reliever/fever reducer, due to the risk of severe allergic reactions.

  • In patients undergoing heart surgery, as use immediately before or after such procedures may pose significant risks.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, wheezing, skin reddening, facial swelling, shock, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in pediatric patients with a history of stomach ulcers or bleeding disorders, those concurrently using anticoagulants or steroid medications, or those taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen). Additionally, exceeding the recommended dosage or duration of treatment increases the risk of gastrointestinal complications.

Healthcare professionals should be vigilant for signs of severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. It is advised to consult a physician promptly in such cases. The use of ibuprofen should not exceed two days, nor should it be administered to children under three years of age unless specifically directed by a healthcare provider.

In cases of suspected overdose, immediate medical attention is required. Healthcare providers should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be advised to discontinue use and consult a physician if any of the following occur: signs of stomach bleeding (e.g., feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain), lack of relief within the first 24 hours of treatment, worsening fever or pain lasting more than three days, presence of redness or swelling in the affected area, or the emergence of any new symptoms. Regular monitoring and assessment of these parameters are essential to ensure patient safety and effective management.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, or blisters, particularly in individuals with a known allergy to aspirin.

Additionally, the use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, including aspirin and naproxen. Patients are advised to adhere strictly to dosing instructions, as taking more than directed or for an extended period may elevate this risk.

Common adverse reactions may include gastrointestinal symptoms. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, or passing bloody or black stools. Persistent stomach pain that does not improve, as well as fever or pain that worsens or lasts beyond three days, should prompt immediate consultation with a healthcare provider. Redness or swelling in the painful area or the emergence of any new symptoms also warrants medical attention.

Patients are advised to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if they have experienced serious side effects from pain relievers or fever reducers. Special caution is recommended for patients who have not been adequately hydrated, have lost significant fluids due to vomiting or diarrhea, or have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke. Asthmatic patients and those on diuretics should also seek medical advice prior to use.

In cases where a child experiences severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, it is crucial to consult a healthcare provider promptly. The product should not be used for more than two days in such instances or administered to children under three years of age unless directed by a physician.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Ibuprofen 572 (ibuprofen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Ibuprofen 572.
Details

Pediatric Use

Pediatric patients under 24 lbs should not be treated without consulting a doctor. For those aged 2 to 3 years weighing 24-35 lbs, the recommended dosage is 5 mL. Children aged 4 to 5 years weighing 36-47 lbs should receive 7.5 mL, while those aged 6 to 8 years weighing 48-59 lbs may be given 10 mL. For children aged 9 to 10 years weighing 60-71 lbs, the dosage is 12.5 mL, and for 11-year-olds weighing 72-95 lbs, the recommended dosage is 15 mL.

Safety considerations are critical for pediatric use. It is advised not to use this medication in children under 3 years of age unless directed by a healthcare professional. Consultation with a doctor is necessary if the child has a history of stomach issues, such as heartburn, or has experienced serious side effects from pain relievers or fever reducers. Additionally, if the child has not been adequately hydrated due to vomiting or diarrhea, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stroke, or asthma, a doctor should be consulted. Caution is also warranted if the child is taking a diuretic.

Warnings include the need for prompt medical attention if a child experiences a severe or persistent sore throat, especially if accompanied by high fever, headache, nausea, or vomiting, as these symptoms may indicate a serious condition. The risk of stomach bleeding is increased in children with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, or those using other NSAIDs, particularly if dosages exceed recommendations or are taken for extended periods.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific mention of pregnancy use, safety concerns, dosage modifications, or special precautions regarding the use of ibuprofen during pregnancy in the provided text. Healthcare professionals should consider the lack of data when prescribing ibuprofen to pregnant patients and weigh the potential risks and benefits. It is advisable to exercise caution and to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to safeguard the patient's health and well-being.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, asthma (wheezing), skin reddening, facial swelling, shock, rash, and blisters. Additionally, severe stomach bleeding has been noted, particularly in children with a history of stomach ulcers or bleeding problems, as well as in those taking blood thinners, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs). Signs indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain. Furthermore, new symptoms have been reported during treatment.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that the medication be taken with food or milk if the patient experiences stomach upset.

Providers should inform patients that using more than the directed dosage or extending the duration of use may increase the risk of heart attack or stroke. Patients should be instructed to discontinue use and consult a doctor if the child exhibits any signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, not achieving relief within the first 24 hours of treatment, worsening fever or pain lasting more than three days, noticing redness or swelling in the painful area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if the stomach bleeding warning applies to the child, if the child has a history of stomach issues such as heartburn, has experienced serious side effects from pain relievers or fever reducers, has not been adequately hydrated, has lost significant fluids due to vomiting or diarrhea, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or a history of stroke, has asthma, or is taking a diuretic.

Additionally, patients should be advised to consult a doctor or pharmacist before use if the child is under medical care for any serious condition or is currently taking any other medications.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the carton prior to use; the product should not be utilized if the carton is opened or if the printed inner seal marked "SEALED for YOUR PROTECTION" is broken or missing. Proper handling and storage conditions are essential to ensure the product remains safe and effective for patient use.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 6-8 hours as needed, not to exceed four doses per day. Patients are advised to take the medication with food or milk if they experience stomach upset. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Ibuprofen 572, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Childrens Ibuprofen 572, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.