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Sodium Flouride

Generic: Sodium Fluoride

Verified·Apr 23, 2026
NDC
42291-741
Route
DENTAL
ICD-10 indication
K02.9

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About Sodium Flouride

What is this medication? Sodium fluoride is a mineral supplement primarily used to prevent dental cavities and strengthen tooth enamel. It works by making the teeth more resistant to acid attacks caused by plaque bacteria and sugars in the mouth. This medication is often prescribed for children and adults who are at a higher risk of developing tooth decay or for those who do not receive adequate fluoride through their local drinking water. In addition to its role in dental health, healthcare providers may use sodium fluoride to treat or prevent mineral deficiencies. It is available in various forms, including oral tablets, drops, and high-concentration topical pastes or gels. By remineralizing weakened enamel and reversing early signs of decay, this medication helps maintain overall oral hygiene and prevents more significant dental issues from developing over time.

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 Flouride. Official source: DailyMed (NLM) · Label effective Jan 15, 2026

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% in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once 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: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of Sodium Fluoride 1.1% toothpaste to a toothbrush. Brush thoroughly once daily for two minutes, preferably at bedtime. 2. After use, adults expectorate. 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 cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of the dental cream which could cause dental fluorosis. Read directions carefully before using. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Adverse reactions
ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. You should call your doctor, or dental professional for medical advise about serious adverse events. To report a serious adverse event or obtain product information, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 (Toll Free).
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.

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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.