Stannous Fluoride
Caries Prophylactic Agents
Sold as OMNI · Burkhart · Enamelon · parodontax · Ionite H
- 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
Plain-language summary, compiled from the cited regulatory records
Stannous fluoride is a compound classified as a caries prophylactic agent [1]. It is approved for use in aiding the prevention of dental cavities, also known as caries [1].
This active ingredient is available under various brand names, including Gum Detoxify, Complete Protection, and Sensitivity and Gum [1]. In the past 12 months, there have been 27 adverse event reports associated with products containing stannous fluoride [2]. The most frequently reported reactions include dyspnoea, arthralgia, back pain, cough, and reports of the drug being ineffective [2].
This is not medical advice. Consult a qualified healthcare professional.
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.