Prescription and over-the-counter medicine
Azelaic acid Brand names: Finacea, Azelex
Azelaic acid (Finacea) is a prescription and over-the-counter medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $0.441 per gram (Azelaic acid 15% gel) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the azelaic acid FDA label on DailyMed (effective November 11, 2021, Sandoz Inc.); the NDA 20428 record on Drugs@FDA; every azelaic acid label on DailyMed.
Highlights of the record
FDA label of November 11, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAzelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
Forms and strengths
- 0.15 g/g
- 0.2 g/g
Gel; aerosol (foam); cream.
On the market
- Earliest approval on file
- September 13, 1995 Azelex, Almirall; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first November 19, 2018; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 5 under generic applications, 2 under brand applications, repackagers included; 3 more under the over-the-counter monograph, without an application
- Last listed patent
- February 28, 2029 Finacea aerosol; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.441 per gram Azelaic acid 15% gel
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2024 0 Class I among all firms' recalls; latest July 23, 2026
- FAERS reports
- 939 through July 30, 2026
What is azelaic acid used for?
From the label: indications and usageAzelaic 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. ( 1 ) Limitations of Use Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
Conditions named in the indications of azelaic acid's FDA labels, with every medicine labeled for each:
From other azelaic acid labelsAcne: INDICATIONS AND USAGE AZELEX ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.
Source: FDA drug label (Azelaic Acid Gel), NDA021470 (Leo Pharma As), as published by Sandoz Inc., effective November 11, 2021 (SPL set 66178511-5c1a-4ecd-bc98-2ceb54e710ac), via openFDA; the full label on DailyMed
Is there a generic for azelaic acid (Finacea)?
The FDA approved the first generic azelaic acid on November 19, 2018. 5 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists azelaic acid from 5 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Finacea aerosol, the last expiring on February 28, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2018 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for azelaic acid (Finacea)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.441 per gram (Azelaic acid 15% gel), down 32% from $0.647 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Azelaic acid 15% gel (generic)
- Finacea 15% foam (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Azelaic acid 15% gel | Generic | $0.441 per gram | n/a | -32% |
| Finacea 15% foam | Brand | $8.33 per gram | n/a | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has azelaic acid been recalled?
The FDA's Enforcement Report lists 3 recalls naming azelaic acid since 2024: 0 Class I (the most serious), 3 Class II, 0 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 23, 2026 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. |
| September 17, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: Market complaints received for gritty texture (grainy) |
| July 22, 2024 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for azelaic acid?
The FDA Adverse Event Reporting System holds 939 reports that list azelaic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 74 are coded as a death and 173 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 else is labeled for the same conditions as azelaic acid?
14 other medicines are given the same way (topical) and in the same FDA class as azelaic acid or labeled mainly for the same use (acne), the same class first. Acne lists all 26 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Salicylic acid | Acne | none listed | $0.102 per patch Callus removers patch | No current entry |
| Benzoyl peroxide | Acne | none listed | $0.0469 per gram 10% wash | No current entry |
| Sulfur | Acne | none listed | n/a | No current entry |
| Tretinoin | Acne | 19 labelers | $0.506 per gram 0.025% cream | No current entry |
| Adapalene | Acne | 34 labelers | $0.504 per gram 0.3% gel | No current entry |
| Benzoyl peroxide and clindamycin | Acne | 11 labelers | $0.622 per gram 1-5% | No current entry |
| Dapsone | Acne | 16 labelers | $0.664 per gram 5% gel | A presentation being discontinued |
| Adapalene and benzoyl peroxide | Acne | 11 labelers | $0.626 per gram 0.3-2.5% | No current entry |
Every medicine labeled for the same conditions as azelaic acid
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does azelaic acid compare with medicines for the same use?
8 side-by-side pages set azelaic acid beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to azelaic acid
- 14 medicines for the same use
- Azelaic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other