Two medicines, side by side
Azelaic acid vs sulfur
Azelaic acid and sulfur are both labeled for acne. Drugs@FDA records approvals of azelaic acid since 1995 and of sulfur since 1940.
Check it at the source: the azelaic acid FDA label on DailyMed (effective November 11, 2021); the sulfur FDA label on DailyMed (effective November 15, 2023).
Highlights of the azelaic acid record
Azelaic acid (Finacea) · label of November 11, 2021
Used for
From the label: indicationsAzelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea ( 1 ). Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. […]
On the market
- Earliest approval on file
- September 13, 1995
- Generic labelers
- 5 labelers
- Pharmacy cost
- $0.441 per gram
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
Highlights of the sulfur record
Sulfur (Bensulfoid) · label of November 15, 2023
Used for
From the label: indicationsSkin Rash Worsened By Heat And Water*
On the market
- Earliest approval on file
- September 17, 1940
- Generic labelers
- none listed
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Azelaic acid label of November 11, 2021, Sulfur label of November 15, 2023); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do azelaic acid and sulfur differ on the record?
Generics: azelaic acid since 2018; sulfur none approved (Drugs@FDA).
| Azelaic acid | Sulfur | |
|---|---|---|
| Labeled for | Acne | Acne |
| Pharmacologic class | n/a | n/a |
| How it works (label) | The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown. | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | September 13, 1995 | September 17, 1940 |
| First generic approved | November 19, 2018 | none |
| Generic labelers (NDC) | 5 labelers | none listed |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.441 per gram (Azelaic acid 15% gel) | n/a |
| 12-month price change | -32% | n/a |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 939 | 8,405 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to azelaic acid
- every medicine labeled for the same conditions