Over-the-counter medicine
Cetylpyridinium
Cetylpyridinium 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 cetylpyridinium FDA label on DailyMed (effective May 8, 2025); every cetylpyridinium label on DailyMed.
Highlights of the record
FDA label of May 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagehelps prevent and reduce plaque that leads to gingivitis, an early form of gum disease bleeding gums
Forms and strengths
- 0.05 mg
- 0.01 mg/20ml
- 0.014 g/ml
- 0.014 g/20ml
- 0.015 mg/20ml
- 0.02 g/20ml
- 0.027 g/100ml
- 0.05 g/ml
- 0.05 g/100ml
- 0.06 g/100g
- 0.07 g/ml
- 0.07 g/100ml
Rinse; mouthwash; liquid; kit; spray.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 48 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 2025 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 755 through July 30, 2026
What is cetylpyridinium used for?
From the label: indications and usagehelps prevent and reduce plaque that leads to gingivitis, an early form of gum disease bleeding gums
Source: FDA drug label (Parodontax Active Gum Health Clear Mint), Haleon US Holdings LLC, effective May 8, 2025 (SPL set 444f931d-5e38-4cda-97ba-98aa0b5fe4f6), via openFDA; the full label on DailyMed
Is there a generic for cetylpyridinium?
No generic cetylpyridinium is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cetylpyridinium been recalled?
The FDA's Enforcement Report lists 1 recall naming cetylpyridinium since 2025: 0 Class I (the most serious), 0 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of cetylpyridinium and that holds 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 |
|---|---|---|---|
| December 26, 2025 | Class III | Haleon US Holdings LLC not a listed maker | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for cetylpyridinium?
The FDA Adverse Event Reporting System holds 755 reports that list cetylpyridinium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 84 are coded as a death and 304 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?
- Cetylpyridinium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other