Over-the-counter medicine
Sodium fluoride
Sodium fluoride is an over-the-counter medicine. No generic is listed; pharmacies paid $0.0975 per mL (Sodium fluoride 5000 ppm paste) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the sodium fluoride FDA label on DailyMed (effective February 16, 2026); every sodium fluoride label on DailyMed.
Highlights of the record
FDA label of February 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageaids in the prevention of dental cavities
Forms and strengths
- 0.02 g/100ml
- 0.03 g/100ml
- 0.05 g/100ml
- 0.09 mg/ml
- 0.1 mg/ml
- 0.1 g/100g
- 0.15 g/100g
- 0.2 mg/ml
- 0.2 g/100g
- 0.22 g/100g
- 0.24 g/100g
- 0.243 g/100g
Paste (dentifrice); mouthwash; gel (dentifrice); rinse; liquid.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 147 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0975 per mL Sodium fluoride 5000 ppm paste
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2014 0 Class I among all firms' recalls; 5 more by firms not listed as its makers
- FAERS reports
- 3,690 through July 30, 2026
What is sodium fluoride used for?
From the label: indications and usageaids in the prevention of dental cavities
Source: FDA drug label (AQUAFRESH CAVITY PROTECTION), Haleon US Holdings LLC, effective February 16, 2026 (SPL set 5484999c-8e6f-430d-99a5-6893a2489467), via openFDA; the full label on DailyMed
Is there a generic for sodium fluoride?
No generic sodium fluoride is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sodium fluoride?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0975 per mL (Sodium fluoride 5000 ppm paste), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sodium fluoride 5000 ppm paste (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Denta 5000 plus cream | Generic | $0.0633 per gram | n/a | -5% |
| Dentagel 1.1% gel | Generic | $0.108 per gram | n/a | +5% |
| Fluoride 0.25 mg tablet chewable | Generic | $0.0774 per tablet | $2.32 | +15% |
| Fluoride 0.5 mg tablet chewable | Generic | $0.0733 per tablet | $2.20 | +0.3% |
| Fluoride 1 mg tablet chewable | Generic | $0.0722 per tablet | $2.17 | +8% |
| Sodium fluoride 0.2% rinse | Generic | $0.0253 per mL | n/a | +2% |
| Sodium fluoride 0.25 (0.55) mg | Generic | $0.0774 per unit | n/a | +15% |
| Sodium fluoride 0.5 mg(1.1 mg) | Generic | $0.0733 per unit | n/a | +0.3% |
| Sodium fluoride 0.5 mg/mL drop | Generic | $0.156 per mL | n/a | -23% |
| Sodium fluoride 1 mg (2.2 mg) | Generic | $0.0722 per unit | n/a | +8% |
| Sodium fluoride 1.1% gel | Generic | $0.108 per gram | n/a | +5% |
| Sodium fluoride 5000 dry mouth | Generic | $0.0975 per mL | n/a | -0.1% |
| Sodium fluoride 5000 plus cream | Generic | $0.0633 per gram | n/a | -5% |
| Sodium fluoride 5000 ppm paste | Generic | $0.0975 per mL | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sodium fluoride been recalled?
The FDA's Enforcement Report lists 5 recalls naming sodium fluoride since 2014: 0 Class I (the most serious), 3 Class II, 2 Class III; 0 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of sodium 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 |
|---|---|---|---|
| August 11, 2023 | Class II | AVKARE LLC not a listed maker | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of … |
| February 13, 2017 | Class III | Colgate Palmolive Co not a listed maker | Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. |
| 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. |
| December 19, 2014 | Class III | 3M Company/3m Espe Dental Products not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box.. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sodium fluoride label say about other medicines?
The sodium fluoride label names no other medicine on this site. The labels of 1 other medicine name sodium fluoride. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (AQUAFRESH CAVITY PROTECTION), Haleon US Holdings LLC, effective February 16, 2026 (SPL set 5484999c-8e6f-430d-99a5-6893a2489467), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium fluoride?
The FDA Adverse Event Reporting System holds 3,690 reports that list sodium fluoride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 504 are coded as a death and 976 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?
- Sodium fluoride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other