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Sodium Fluoride 5000 Plus

Generic: Sodium Fluoride

Verified·Apr 23, 2026
Manufacturer
Cypress Pharmaceutical
NDC
69367-309
RxCUI
392038
Route
DENTAL
ICD-10 indication
Z29.3

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About Sodium Fluoride 5000 Plus

What is this medication? Sodium Fluoride 5000 Plus is a high-potency prescription fluoride toothpaste designed to prevent dental caries and protect tooth enamel. It delivers a significantly higher concentration of fluoride compared to traditional store-bought toothpastes, making it more effective at reversing early signs of tooth decay. This medication is often recommended for individuals who have a high risk of cavities, including those with certain medical conditions, receding gums, or dry mouth caused by other medications. The medication works by promoting remineralization, which is the process of replacing lost minerals in the tooth surface to keep it strong. By hardening the enamel, it makes the teeth more resilient against the acidic byproducts of bacteria found in the mouth. Patients typically use this product once a day, usually at bedtime, to provide maximum contact time with the teeth for the best possible results in maintaining oral health.

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 5000 Plus. Official source: DailyMed (NLM) · Label effective Jul 5, 2023

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 SF 5000 Plus brand of 1.1% sodium fluoride 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 SF 5000 Plus 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. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Adverse reactions
ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.
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. 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

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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.