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Sodium Fluoride 5000 ppm Enamel Protect

Generic: Sodium Fluoride1.1%, Potassium Nitrate 5%

Verified·Apr 23, 2026
Manufacturer
Colgate Palmolive
NDC
11527-745
Route
DENTAL
ICD-10 indication
K02.9

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About Sodium Fluoride 5000 ppm Enamel Protect

What is this medication? Sodium Fluoride 5000 ppm Enamel Protect is a high-concentration prescription toothpaste used primarily to prevent dental cavities and strengthen tooth enamel. It contains a significantly higher level of fluoride compared to standard over-the-counter toothpastes, which helps to remineralize areas of the teeth that have been weakened by acid-producing bacteria. By incorporating more minerals back into the tooth surface, the medication makes the enamel more resistant to decay and helps stop the progression of early-stage cavities.

In addition to preventing tooth decay, this medication is frequently prescribed for individuals who suffer from tooth sensitivity or have a high risk of developing root caries. The formula works by protecting exposed root surfaces and creating a barrier that reduces discomfort caused by hot, cold, or sweet stimuli. Because of its potency, it is meant to be used as part of a daily oral hygiene routine under the guidance of a dentist to ensure the teeth remain healthy and structurally sound.

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 ppm Enamel Protect. Official source: DailyMed (NLM) · Label effective Jan 4, 2021

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, acids, 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 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a 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 in used in areas where 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 and older: Apply at least a 1 inch strip of Sodium Fluoride 5000 ppm Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (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: 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 infants and 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.