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Sodium Fluoride and Potassium Nitrate

Generic: Sodium Fluoride and Potassium Nitrate

Verified·Apr 23, 2026
Manufacturer
Colgate Palmolive
NDC
69367-318
Route
ORAL
ICD-10 indication
K02.9

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About Sodium Fluoride and Potassium Nitrate

What is this medication?

Sodium fluoride and potassium nitrate is a combination prescription medication used primarily to treat dental sensitivity and prevent tooth decay. Sodium fluoride is a mineral that works by strengthening the tooth enamel and making it more resistant to the acid produced by bacteria, which helps to prevent cavities and remineralize weak spots. Potassium nitrate acts as a desensitizing agent that reaches the nerves inside the teeth to block pain signals caused by external stimuli such as hot, cold, or sweet foods and drinks.

This medication is typically prescribed in the form of a high-strength toothpaste or topical gel for patients who require more intensive care than over-the-counter products provide. It is particularly beneficial for individuals with receding gums, exposed tooth roots, or those undergoing certain dental procedures that increase sensitivity. By using this combination regularly, patients can maintain better oral hygiene and protect their teeth from long-term damage while managing chronic tooth discomfort.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Sodium Fluoride and Potassium Nitrate. Official source: DailyMed (NLM) · Label effective Apr 18, 2024

Indications and usage
INDICATIONS AND USAGE A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
Dosage and administration
DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: Adults and children 12 years of age or older, apply at least a 1 inch strip of Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice daily, (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: consult a dentist or physician.
Contraindications
CONTRAINDICATIONS Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
Warnings
WARNINGS Not for systemic treatment - DO NOT SWALLOW. Keep out of the reach of children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Adverse reactions
ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use in pregnancy
Pregnancy Teratogenic Effects Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis, which becomes evident in childhood.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Prior authorization & coverage

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.