ℹ️ Compiled from public regulatory records · Last regulator revision: January 13, 2026🚩 Report this page
Stannous Fluoride
Caries Prophylactic Agents
Sold as OMNI · Burkhart · Enamelon · parodontax · Ionite H
US FDA
- Drug class
- Caries Prophylactic Agents
- Availability
- Over-the-counter
- Routes
- Dental, Oral
- Markets covered
- 1
- Products on record
- 16
- FDA reports (12 mo)
- 27
Overview
Stannous Fluoride is an active pharmaceutical ingredient in the Caries Prophylactic Agents group (A01AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 16 | January 13, 2026 |
USUnited States· FDA
16 products
Uses
Uses Aids in the prevention of dental cavities (caries).
How to take
Sources & citations
- [1]FDA DailyMed · 042636cf-8b61-40… · revised October 11, 2023 [PDF]
- [2]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.