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Anticavity

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Active ingredient
Sodium Fluoride 0.02 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
February 5, 2026
Active ingredient
Sodium Fluoride 0.02 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
February 5, 2026
Manufacturer
Publix Super Markets, Inc.
Registration number
M021
NDC root
56062-971

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Drug Overview

Sodium Fluoride & Acidulated Phosphate Topical Solution is an alcohol-free anticavity mouthwash designed to help you maintain good oral health. It aids in the prevention of dental cavities by restoring enamel and strengthening your teeth, making them more resistant to decay. Additionally, this mouthwash helps kill bad breath germs, cleans your entire mouth, and freshens your breath with a pleasant mint flavor.

With a volume of 33.8 FL OZ (1.05 QT), this mouthwash can be a valuable part of your daily dental care routine, ensuring that your mouth stays clean and healthy.

Uses

You can use this product to help keep your teeth and mouth healthy in several ways. It aids in the prevention of dental cavities, which means it helps stop holes from forming in your teeth. Additionally, it works to restore enamel, the protective outer layer of your teeth, and strengthens them to better fight off cavities.

This product also targets bad breath by killing the germs that cause it, ensuring your mouth stays clean and fresh. With its ability to clean the entire mouth, you can enjoy fresher breath and a more confident smile.

Dosage and Administration

To use this mouth rinse effectively, you should follow a simple routine. For adults and children aged 6 years and older, rinse twice a day after brushing your teeth with toothpaste. Take 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. Remember, do not swallow the rinse.

After using the mouth rinse, it's important not to eat or drink anything for 30 minutes to allow the rinse to work effectively. If you're helping a child under 12, make sure to teach them how to rinse properly to avoid swallowing the rinse, and supervise them until they can do it on their own. For children under 6 years old, it's best to consult a dentist or doctor before using the rinse.

What to Avoid

It's important to be cautious when using this product. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. This ensures your safety and well-being.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always use it as directed to avoid any potential issues.

Side Effects

You may not experience any specific adverse reactions or warnings while using this medication, as there are no notable side effects reported. However, it's always important to monitor how you feel and discuss any concerns with your healthcare provider. If you notice anything unusual, don't hesitate to reach out for guidance.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. If you accidentally swallow more than what is intended for rinsing, seek emergency medical help immediately or contact a Poison Control Center.

Additionally, always follow the recommended usage instructions to avoid any potential risks. If you experience any unusual symptoms or reactions while using this product, stop use and call your doctor for further guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

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

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details on hand can help healthcare professionals provide the best care. Always remember, when in doubt, it’s better to be safe and get help.

Pregnancy Use

The safety of this product during pregnancy has not been established, so it's important to approach its use with caution. While there are no specific contraindications listed, the effects on fetal development are not well studied, which means potential risks to the fetus are unclear. Therefore, if you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider for personalized advice before using this product.

Currently, there are no specific dosage modifications recommended for pregnant individuals, but your healthcare provider can guide you on the best course of action based on your unique situation. Always prioritize open communication with your healthcare team regarding any medications or products you may consider 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 child.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is needed for rinsing, seek medical help or contact a Poison Control Center immediately.

For children aged 6 years and older, you can use the rinse twice daily after brushing their teeth. They should swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for one minute and then spit it out. Make sure they do not swallow the rinse and avoid eating or drinking for 30 minutes afterward. It's essential to teach children under 12 good rinsing habits to minimize swallowing and supervise them until they can rinse independently. For children under 6, please consult 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

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Your healthcare provider will monitor your renal function regularly, especially through tests that measure creatinine clearance (a test that estimates how well your kidneys filter waste).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety. If you have moderate to severe renal impairment, you may require a reduced dose of your medication to avoid potential complications. Always discuss your kidney health with your doctor to ensure the best care.

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 impairment. 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.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no known interactions between this medication and other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health situation. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 68-77°F (20-25°C). This temperature range helps maintain its effectiveness. Be aware that if the product is exposed to cold weather, it may temporarily appear cloudy, but this does not affect its safety or function.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, please follow them carefully to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Sodium Fluoride & Acidulated Phosphate Topical Solution?

It is an alcohol-free anticavity mouthwash that helps prevent dental cavities and freshens breath.

How does this mouthwash work?

It aids in the prevention of dental cavities, restores enamel, strengthens teeth, kills bad breath germs, and cleans the entire mouth.

What is the recommended usage for adults and children over 6?

Use twice daily after brushing your teeth, swishing 10 mL (2 teaspoonfuls) for 1 minute before spitting it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

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

Get medical help or contact a Poison Control Center immediately.

Is this mouthwash safe for children under 6?

Consult a dentist or doctor before use for children under 6 years of age.

What precautions should pregnant women take?

Pregnant women should consult their healthcare provider before use, as the safety of this product during pregnancy has not been established.

How should I store this mouthwash?

Store at a controlled room temperature between 68-77°F (20-25°C).

Are there any known side effects?

No specific adverse reactions or warnings are listed for this product.

What should I do if I have renal impairment?

Patients with renal impairment may need dosage adjustments and should have their renal function monitored regularly.

Packaging Info

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

Packaging configurations for Anticavity.
Details

Drug Information (PDF)

This file contains official product information for Anticavity, 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 aids in the restoration of enamel and helps strengthen teeth to combat cavity formation. Additionally, it possesses antimicrobial properties that effectively kill bad breath germs, contributing to overall oral hygiene. This formulation cleans the entire mouth and provides breath-freshening benefits.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes post-rinsing to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child demonstrates the ability to use the rinse independently and safely.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount for rinsing is accidentally swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

In the event of accidental ingestion beyond the recommended use for rinsing, immediate medical assistance is required. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

It is crucial to ensure that patients are aware of the potential risks associated with the misuse of this product. Proper education on the correct usage and the importance of adhering to the recommended guidelines can help mitigate the risk of accidental ingestion.

Side Effects

There are no specific adverse reactions or warnings associated with the use of this product. Clinical trials and postmarketing experiences have not identified any notable adverse reactions. As such, healthcare professionals should continue to monitor patients for any unexpected effects during treatment, although no documented adverse reactions have been reported to date.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Anticavity (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anticavity.
Details

Pediatric Use

Pediatric patients should be closely monitored when using this product. It is essential to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is crucial that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following rinsing. Caregivers should instruct children under 12 years in proper rinsing techniques to minimize the risk of swallowing and supervise their use until they are capable of rinsing without assistance.

For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Caution is advised as the effects on fetal development are not well studied. Potential risks to the fetus are not detailed; therefore, it is essential for pregnant patients to consult their healthcare provider for personalized advice before use. No specific dosage modifications for pregnant individuals are provided.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in breast milk remain undetermined. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate the risk of adverse effects.

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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount used for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use and to act promptly in such situations to ensure their safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 68-77°F (20-25°C). Care should be taken during cold weather, as it may cause temporary cloudiness in the product. No special container requirements or handling needs are specified beyond maintaining the recommended temperature range.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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