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Sodium Fluoride 1.1%

Verified·Oct 26, 2026
NDC
71085-074
ICD-10 indication
K02.9

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About Sodium Fluoride 1.1%

What is this medication? Sodium fluoride 1.1% is a prescription-strength topical fluoride treatment primarily used to prevent dental cavities and tooth decay. This medication works by increasing the mineral content of the tooth enamel, making the surface harder and more resistant to the corrosive acids produced by plaque bacteria and sugary foods. By promoting remineralization, it can help strengthen teeth and may even repair the earliest stages of decay before a permanent cavity develops. Dentists often prescribe this medication for individuals who are at an increased risk for dental problems caused by factors such as dry mouth, orthodontic appliances, or a high frequency of previous cavities. It is commonly provided as a gel or a concentrated toothpaste and is usually applied once daily at bedtime after normal brushing and flossing. For the best results, users should avoid eating, drinking, or rinsing their mouths for at least thirty minutes after application so the fluoride has enough time to be absorbed by the teeth.

Copay & patient assistance

  • Patient Copay Amount: Not Publicly Available
  • Maximum Annual Benefit Limit: Not Publicly Available
  • Core Eligibility Restrictions: Not Publicly Available
  • RxBIN, PCN, and Group numbers: Not Publicly Available

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Prescribing information

From the FDA-approved label for Sodium Fluoride 1.1%. Official source: DailyMed (NLM) · Label effective Nov 14, 2025

Indications and usage
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. 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% Dental Gel in a squeeze-tube is easily applied onto a toothbrush. This prescription dental gel should be used once daily following use 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 pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime. After use, adults expectorate gel. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.
Contraindications
CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Warnings
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently can not perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental gel, which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.
Adverse reactions
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Sheffield Pharmaceuticals, LLC. at 1-800-222-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use in pregnancy
Pregnancy: 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.

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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.