Over-the-counter medicine
Stannous fluoride
Stannous fluoride is an over-the-counter medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Over the counter
Check it at the source: the stannous fluoride FDA label on DailyMed (effective December 11, 2025); every stannous fluoride label on DailyMed.
Highlights of the record
FDA label of December 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAids in the prevention of dental decay.
Forms and strengths
- 0.004 g/g
- 0.00454 g/g
- 0.11 g/100g
- 0.116 g/120g
- 0.14 g/100g
- 0.15 g/100g
- 0.16 g/100g
- 0.4 mg/100g
- 0.454 g/100g
- 0.63 mg/100ml
- 0.969 mg/g
- 1 mg/g
Paste (dentifrice); paste; gel; gel (dentifrice); rinse.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 41 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2015 0 Class I among all firms' recalls; 6 more by firms not listed as its makers
- FAERS reports
- 982 through July 30, 2026
What is stannous fluoride used for?
From the label: indications and usageAids in the prevention of dental decay.
Source: FDA drug label (KIDS CHOICE), Massco Dental A Division of Dunagin Pharmaceuticals, effective December 11, 2025 (SPL set cbf7907e-72c7-4328-8bd4-bf70daa35ef9), via openFDA; the full label on DailyMed
Is there a generic for stannous fluoride?
No generic stannous fluoride is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has stannous fluoride been recalled?
The FDA's Enforcement Report lists 6 recalls naming stannous fluoride since 2015: 0 Class I (the most serious), 6 Class II, 0 Class III; 0 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of stannous fluoride and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 28, 2017 | Class II | GSK Consumer Healthcare not a listed maker | Presence of Foreign Substance: possibility of the presence of metal in the product. |
| March 6, 2017 | Class II | GSK Consumer Healthcare not a listed maker | Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent |
| July 15, 2015 | Class II | GlaxoSmithkline Consmer Healthcare not a listed maker | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for stannous fluoride?
The FDA Adverse Event Reporting System holds 982 reports that list stannous fluoride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 41 are coded as a death and 107 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Stannous fluoride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other