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Oral Pain Relief

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
December 27, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
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 2011
Label revision date
December 27, 2017
Manufacturer
Kareway Product, Inc.
Registration number
part356
NDC root
67510-0058
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

Orajel gel is a topical medication designed to provide instant pain relief for toothaches. It contains benzocaine (a local anesthetic) at a maximum strength of 20%, which works by temporarily numbing the area around the affected tooth to alleviate discomfort.

If you're experiencing a toothache, Orajel gel can help ease your pain quickly, allowing you to feel more comfortable while you seek further dental care.

Uses

If you're dealing with a toothache, this medication can help by temporarily relieving your pain. It's designed specifically for that purpose, so you can find some comfort while addressing the underlying issue.

Rest assured, this medication does not have any known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safer option for those concerned about potential risks. Always consult with a healthcare professional for personalized advice and treatment options.

Dosage and Administration

To use this product effectively, you should apply a small amount directly to the cavity and the gum area surrounding your teeth. This topical application can be done up to four times a day, or as your dentist or doctor advises.

If you are using this product for a child under 12 years old, make sure they are supervised during application. For children younger than 2 years, it’s important to consult with a dentist or doctor before use to ensure safety and proper guidance.

What to Avoid

It's important to use this medication responsibly. You should not take it for more than 7 days unless your dentist or doctor specifically instructs you to do so. Following this guideline helps ensure your safety and the effectiveness of the treatment.

While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance), it's always best to use medications as directed. If you have any questions or concerns about your treatment, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, it's important not to use this product. You should also avoid using it for more than 7 days unless directed by a dentist or doctor.

If you experience any swelling, rash, or fever, or if irritation, pain, or redness continues or worsens, stop using the product and consult a doctor. Additionally, if your symptoms do not improve within 7 days, seek medical advice. Always keep this product out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. If you have a history of allergies to local anesthetics like procaine, butacaine, benzocaine, or other "caine" anesthetics, do not use this product. It's also crucial not to exceed the recommended dosage or use it for more than 7 days unless your dentist or doctor advises otherwise.

If you notice any swelling, rash, or fever, or if irritation, pain, or redness continues or worsens, stop using the product and contact your doctor. Additionally, if your symptoms do not improve within 7 days, seek medical advice. In the event of an overdose, get medical help immediately or contact a Poison Control Center.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Don’t wait to see if symptoms improve; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help right away.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been evaluated. While there are no specific contraindications listed, caution is advised since the effects of benzocaine on pregnancy have not been established. There is also no detailed information available regarding potential risks to the fetus.

Before using this product, it is essential to consult with your healthcare provider to discuss any concerns and ensure it is safe for you and your baby. Remember, your health and the health of your developing child are the top priority.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. Your health and the well-being of your baby are important, and your provider can offer personalized advice.

Pediatric Use

When using this product for children aged 2 years and older, you can apply a small amount to the cavity and the gum area around the teeth. It’s safe to use up to four times a day, or as your dentist or doctor recommends. For children under 12, it's important that they are supervised while using the product to ensure safety and proper application. If your child is under 2 years old, please consult with a dentist or doctor before use to get specific guidance.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be aware of potential interactions when considering any medication. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics, you should avoid using this product. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

Additionally, while there are no specific interactions with other drugs or laboratory tests noted, it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps your provider make the best decisions for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

This medication is applied directly to the skin (topically) and can be used up to four times a day, or as directed by your dentist or doctor. It is specifically designed to provide temporary relief for toothaches until you can see a dentist. It's important to remember that this product should not be used continuously; it is meant for short-term use only.

FAQ

What is Orajel gel used for?

Orajel gel is used for instant pain relief from toothaches.

How does Orajel gel work?

It temporarily relieves pain due to toothaches by applying a topical anesthetic.

What is the recommended dosage for adults and children over 2 years?

Apply a small amount to the cavity and surrounding gum up to 4 times daily or as directed by a dentist or doctor.

Can children use Orajel gel?

Children under 12 should be supervised while using it, and those under 2 years should consult a dentist or doctor.

Are there any contraindications for using Orajel gel?

Do not use if you have a history of allergy to local anesthetics like benzocaine.

What should I do if symptoms do not improve?

Stop use and ask a doctor if symptoms do not improve in 7 days or if swelling, rash, or fever develops.

Is Orajel gel safe to use during pregnancy?

The safety of Orajel gel during pregnancy has not been established; consult a healthcare provider before use.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

How should I store Orajel gel?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Oral Pain Relief (oral pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Oral Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Orajel gel is an oral pain reliever indicated for the instant relief of toothache. It contains 20% benzocaine as the active ingredient, providing maximum strength for effective pain management. The product is available in a net weight of 0.42 ounces (11.9 grams).

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothaches.

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

Dosage and Administration

Adults and children aged 2 years and older should apply a small amount of the product directly to the cavity and the gum surrounding the teeth. This application may be performed up to four times daily or as directed by a dentist or physician.

For children under 12 years of age, supervision during the use of this product is recommended to ensure safety and proper application. In the case of children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

The product is intended for topical application specifically to the cavity and the surrounding gum area.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage for more than 7 days without the guidance of a dentist or doctor. Prolonged use beyond this duration may lead to potential adverse effects.

Warnings and Precautions

Patients with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. The potential for severe allergic reactions necessitates careful screening for such allergies prior to administration.

This product should not be used for longer than directed, specifically not exceeding a duration of 7 days, unless otherwise instructed by a qualified healthcare professional, such as a dentist or physician. Adherence to this guideline is crucial to prevent potential complications associated with prolonged use.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: development of swelling, rash, or fever; persistence or worsening of irritation, pain, or redness; or if symptoms do not show improvement within 7 days. These signs may indicate an adverse reaction or the need for further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action is essential to mitigate any potential health risks associated with overdose.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning is the allergy alert; individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product.

In clinical practice, it is advised that patients do not exceed the recommended dosage for more than 7 days unless directed by a dentist or doctor. If patients experience swelling, rash, or fever, or if irritation, pain, or redness persists or worsens, they should discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days, medical advice should be sought.

It is crucial to keep this product out of reach of children. In the event of an overdose, patients or caregivers should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

The use of this product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, no additional monitoring or dosage adjustments are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Oral Pain Relief (oral pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Pain Relief.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply a small amount of the product to the cavity and around the gums surrounding the teeth, with a maximum usage of up to 4 times daily or as directed by a dentist or doctor.

For children under 12 years of age, supervision is recommended during the use of this product to ensure safety and proper application.

In infants and children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. Caution is advised, as the safety of benzocaine during pregnancy has not been established. There is no specific information available regarding risks to the fetus. No dosage modifications are recommended for pregnant individuals. It is essential for pregnant patients or those planning to become pregnant to consult a healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information provided about the potential for excretion in breast milk or any associated risk to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of overdose related to the specific agent involved.

It is critical to document all relevant information regarding the overdose, including the substance, amount ingested, time of ingestion, and any symptoms presented, to facilitate effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to exceed the recommended dosage or use the medication for more than 7 days unless directed by a dentist or doctor. It is important for patients to monitor their symptoms and to stop using the medication if they experience swelling, rash, or fever. Additionally, they should seek medical advice if irritation, pain, or redness persists or worsens, or if their symptoms do not improve within 7 days.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically and may be used up to four times daily, or as directed by a dentist or doctor. It is specifically intended for temporary relief of toothache until a dental consultation can be arranged, and continuous use is not recommended.

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

Drug Information (PDF)

This file contains official product information for Oral Pain Relief, 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 Oral Pain Relief, 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.

Learn more in our Editorial Policy

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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.