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Active ingredient
Sodium Fluoride 0.15 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
October 17, 2025
Active ingredient
Sodium Fluoride 0.15 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
October 17, 2025
Manufacturer
Target
Registration number
M021
NDC root
11673-308

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Drug Overview

This drug is designed to help prevent dental cavities, making it a useful option for maintaining oral health. By using this medication, you can support your efforts to keep your teeth strong and reduce the risk of cavities forming.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing cavities, which are small holes in your teeth caused by decay. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you have any questions about your brushing routine, don’t hesitate to ask your dentist or doctor for guidance.

For children under 6 years old, it's essential to teach them good brushing and rinsing habits to help prevent swallowing toothpaste. You should supervise their brushing until they are able to do it on their own effectively. If your child is under 2 years old, it's best to consult with a dentist or doctor before starting any dental care routine.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact Poison Control immediately.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product, always use it as directed to ensure your safety and well-being.

Side Effects

It’s important to keep this product out of reach of children under 6 years of age. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact Poison Control immediately.

Always ensure that this product is stored safely to prevent any accidental ingestion by young children. Your safety and the safety of your loved ones is a priority.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact Poison Control immediately.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact Poison Control. Overdosing can lead to serious health issues, so don’t hesitate to reach out for assistance.

Signs of an overdose may not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to get help right away. Always prioritize your safety and well-being by acting quickly in these situations.

Pregnancy Use

When it comes to using this product during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or products you consider during this important time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the information provided does not include specific guidelines or considerations for nursing mothers or lactation (the process of producing milk). This means that there are no detailed recommendations or warnings regarding the use of this medication while breastfeeding.

Always consult with your healthcare provider for personalized advice and to discuss any potential risks or effects on your milk production or your baby. Your healthcare provider can help you make informed decisions that are best for you and your child.

Pediatric Use

It's important to keep this product out of reach of children, especially those under 6 years old. If a child accidentally swallows more than the recommended amount used for brushing, seek medical help or contact Poison Control immediately. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or doctor.

For children under 6, it's essential to teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children while they brush until they can do it safely on their own. If your child is under 2 years old, consult with a dentist or doctor before use.

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 considering this medication, it’s important to consult with a healthcare provider. 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and ensure that any medications you take are safe for you. Regular liver function tests (which check how well your liver is working) may be necessary to keep track of your health. Always communicate openly with your doctor about your liver condition and any concerns you may have.

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 best performance and safety of your product, store it at room temperature and protect it from freezing. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you open the tube but do not use the contents within a specified time frame, be sure to discard it to avoid any potential safety issues. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally, brushing your teeth thoroughly after each meal or at least twice a day, unless your dentist or doctor advises otherwise. If you have children under 6, make sure to teach them proper brushing and rinsing habits to prevent swallowing the product, and supervise them until they can brush without help. For children under 2 years old, consult a dentist or doctor before use.

It's important to keep this medication out of reach of children, especially those under 6 years old. If a child accidentally swallows more than the recommended amount, seek medical help or contact Poison Control immediately.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

What are the brushing instructions for adults and children 2 years and older?

Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor.

What should I do for children under 6 years of age?

Instruct them in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without help.

What is recommended for children under 2 years of age?

Consult a dentist or doctor before use.

Are there any contraindications for this drug?

No contraindications are listed.

What should I do if more than the recommended amount is swallowed?

Get medical help or contact Poison Control right away.

How should this drug be stored?

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

Is there any information regarding the use of this drug during pregnancy?

No specific information is provided regarding its use during pregnancy.

What about nursing mothers or lactation?

There are no specific statements or considerations regarding nursing mothers or lactation.

What precautions should be taken for children?

Keep out of reach of children under 6 years of age.

Packaging Info

Below are the non-prescription pack sizes of Target (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Target.
Details

Drug Information (PDF)

This file contains official product information for Target, 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 prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until the child is capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with Poison Control is advised.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of the importance of keeping this product out of reach of children, particularly those under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control center immediately.

These precautions are essential to ensure the safety of young children, as accidental ingestion may lead to serious health concerns. It is recommended that caregivers remain vigilant and adhere to these guidelines to prevent any adverse reactions associated with misuse.

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 necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Target (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Target.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with Poison Control is advised.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. Children under 6 years of age should be guided in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is necessary until children are capable of using the product without assistance.

For infants and children under 2 years of age, consultation with a dentist or doctor is advised 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy, including any safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific statements or considerations regarding lactating mothers or lactation in the provided text. Therefore, healthcare professionals should exercise caution and consider the absence of data when advising on the use of this medication in nursing mothers and breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 have not been defined.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring the patient for any signs of distress is essential.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to have the product's labeling and any relevant medical history available when contacting medical professionals or poison control for guidance.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact Poison Control immediately. This guidance is crucial for ensuring patient safety and preventing adverse effects related to accidental ingestion.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing.

To maintain the quality of the product, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not used within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

Patients should be instructed to administer the product orally, brushing teeth thoroughly after each meal or at least twice daily, or as directed by a dentist or doctor. For children aged 2 years and older, it is important to supervise brushing and rinsing habits to minimize swallowing. Clinicians should advise that children under 6 years of age require supervision until they can brush without assistance, and that those under 2 years of age should consult a dentist or doctor before use.

Additionally, it is crucial to keep the product out of reach of children, particularly those under 6 years of age. In the event of accidental ingestion of more than the recommended amount, patients should seek medical assistance or contact Poison Control immediately.

Drug Information (PDF)

This file contains official product information for Target, 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 Target, 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.