Sodium Fluoride
Active ingredient · 2 therapeutic classes
Sold as Hismile · Fluoride · DawnMist · Anticavity · Zap APF
- Drug class
- Fluoride
- Availability
- Prescription and OTC
- Routes
- Dental, Oral, Topical, Buccal
- Markets covered
- 2
- Products on record
- 172
- FDA reports (12 mo)
- 246
Overview
Plain-language summary, compiled from the cited regulatory records
Sodium Fluoride is a medication classified as a Caries Prophylactic Agent [1]. It is approved for once-daily self-administered systemic use to prevent dental caries in pediatric patients [1]. The effectiveness of fluoride in reducing dental caries has been established through the ingestion of fluoridated drinking water during tooth development [1]. Sodium Fluoride Chewable Tablets are intended as a fluoride supplement for pediatric patients aged 3 years and older living in areas where the drinking water is not fluoridated [1].
This active ingredient is available under various brand names, including Prime Tooth Care Hami Melon and Colgate Max Fresh Cool Mint [1]. In the past 12 months, there have been 246 adverse event reports associated with Sodium Fluoride [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 137 | May 31, 2026 |
| GB United Kingdom | MHRA | 35 | May 22, 2026 |
USUnited States· FDA
137 products
Uses
Uses Helps protect against cavities.
How to take
GBUnited Kingdom· MHRA
35 products
Uses
Prevention of dental caries in adolescents and adults, particularly amongst patients at risk from multiple caries (coronal and/or root caries).
How to take
Sources & citations
- [1]FDA DailyMed · 0ae98f28-7e78-43… · revised October 25, 2023 [PDF]
- [2]MHRA (UK) · PL000490057 · revised September 12, 2025
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.