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PreviDent 5000 Kids

Generic: Sodium Fluoride

Verified·Apr 23, 2026
Manufacturer
Colgate Palmolive
NDC
0126-0311
RxCUI
392038
Route
DENTAL
ICD-10 indication
Z29.3

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About PreviDent 5000 Kids

What is this medication? PreviDent 5000 Kids is a prescription-strength fluoride toothpaste designed to help prevent dental cavities and tooth decay in pediatric patients. It contains a high concentration of sodium fluoride, which is significantly more potent than the levels found in standard over-the-counter toothpaste. By remineralizing tooth enamel, this medication helps to strengthen the teeth and makes them more resistant to the acid produced by bacteria and sugars in the mouth.

This medication is typically prescribed for children who are at a high risk for developing cavities or who have specific dental health needs that require extra protection. It is generally used once daily, often at bedtime, in place of regular toothpaste to provide maximum benefit. Because of its high fluoride content, it must be used according to a dentist's specific instructions to ensure safety and effectiveness in protecting a child's developing 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 PreviDent 5000 Kids. Official source: DailyMed (NLM) · Label effective Sep 1, 2023

Indications and usage
INDICATIONS AND USAGE A dental caries preventive; for once daily self-applied topical use. PreviDent® 5000 Kids brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be 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 pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 BoosterPlus to a toothbrush. Brush teeth thoroughly once daily for two minutes, preferably at bedtime, in place of your regular toothpaste. 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 toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. 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.
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.