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Sodium Fluoride 5000 PPM

Generic: Sodium Fluoride

Verified·Apr 23, 2026
NDC
11527-704
RxCUI
392038
Route
DENTAL
ICD-10 indication
Z29.8

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About Sodium Fluoride 5000 PPM

What is this medication? Sodium Fluoride 5000 PPM is a high-potency prescription dental treatment used primarily to prevent and control tooth decay. While standard over-the-counter toothpastes contain a lower concentration of fluoride, this professional-strength formula provides a much higher dose to help strengthen tooth enamel and make it more resistant to the acids produced by plaque bacteria. It is frequently prescribed for individuals who are at a high risk for developing cavities, including those with chronic dry mouth, extensive dental work, or those currently undergoing orthodontic treatment. This medication works by promoting the remineralization of teeth, which helps to repair early signs of decay and prevents the formation of new cavities. In addition to protecting the enamel, it can also help reduce tooth sensitivity by fortifying exposed root surfaces. Most patients are instructed to use it once daily, typically at bedtime, in place of their regular toothpaste as directed by a dentist. Because of its high fluoride content, it is important to follow all usage instructions carefully and ensure the product is not swallowed.

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 5000 PPM. Official source: DailyMed (NLM) · Label effective Apr 1, 2020

Indications and usage
INDICATIONS AND USAGE: A dental caries preventive and sensitive toothpaste; for twice daily self-applied topical use,following by rinsing, helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adults 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 5000 ppm Sensitive 1.1% sodium fluoride toothpaste with 5% potassium nitrate 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 pediatric patients 12 years of age or older, apply at least a 1 inch strip of Sodium Fluoride 5000 ppm 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 dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age:consultant 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 Sheffield Pharmaceuticals, LLC. at 1-800-222-1087 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.

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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.