Over-the-counter medicine
Pyrithione
Pyrithione 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 pyrithione FDA label on DailyMed (effective September 2, 2026); every pyrithione label on DailyMed.
Highlights of the record
FDA label of September 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagehelps prevent recurrence of flaking and itching associated with dandruff.
Forms and strengths
- 20 mg
- 0.0095 g/ml
- 0.01 g/ml
- 0.1 g/100ml
- 0.25 g/100ml
- 0.3 g/100ml
- 0.5 g/100ml
- 0.95 g/100ml
- 1 g/100ml
- 1 mg/ml
- 1 mg/g
- 1 g/100g
Shampoo; lotion/shampoo; liquid; lotion; cream.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 96 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)
- No recall recorded
- FAERS reports
- 587 through July 30, 2026
What is pyrithione used for?
From the label: indications and usagehelps prevent recurrence of flaking and itching associated with dandruff.
Source: FDA drug label (Head and Shoulders Scalp Restore Nourishing), The Procter & Gamble Manufacturing Company, effective September 2, 2026 (SPL set 5a8a42d2-8610-1dfb-e063-6294a90abc7a), via openFDA; the full label on DailyMed
Is there a generic for pyrithione?
No generic pyrithione 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 FAERS reports show for pyrithione?
The FDA Adverse Event Reporting System holds 587 reports that list pyrithione among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 89 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?
- Pyrithione side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other