Over-the-counter medicine
Undecylenic acid
Undecylenic acid 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 undecylenic acid FDA label on DailyMed (effective July 9, 2026); every undecylenic acid label on DailyMed.
Highlights of the record
FDA label of July 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFor the treatment of athlete's foot,jock, itch, and ringworm.
Forms and strengths
- 0.25 g
- 0.13 g/ml
- 0.25 g/ml
- 0.25 mg/30ml
- 2 mg/10ml
- 2 mg/20ml
- 2.25 g/9g
- 3.75 mg/15ml
- 4.55 g/37.5ml
- 10 g/100ml
- 10 g/100g
- 11 g/100ml
Liquid; spray; solution; cream; solution/ drops.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 52 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 2026 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 140 through July 30, 2026
What is undecylenic acid used for?
From the label: indications and usageFor the treatment of athlete's foot,jock, itch, and ringworm.
Conditions named in the indications of undecylenic acid's FDA labels, with every medicine labeled for each:
From other undecylenic acid labelsFungal infections: Use For the treatment of athlete's foot,jock, itch, and ringworm.
Pain: Uses Uses for relief and treatment of pain,soreness, and inflammation from nail fungus.
Source: FDA drug label (ZENJBUST Undecylenic Acid 25% Antifungal Pen), Shenzhen Xituo Electronics Co., Ltd, effective July 9, 2026 (SPL set 563a6704-f662-3f08-e063-6394a90a4369), via openFDA; the full label on DailyMed
Is there a generic for undecylenic acid?
No generic undecylenic acid is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has undecylenic acid been recalled?
The FDA's Enforcement Report lists 3 recalls naming undecylenic acid since 2026: 0 Class I (the most serious), 3 Class II, 0 Class III; 3 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of undecylenic acid 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 |
|---|---|---|---|
| April 8, 2026 | Class II | Blaine Labs Inc not a listed maker | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for undecylenic acid?
The FDA Adverse Event Reporting System holds 140 reports that list undecylenic acid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 45 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.
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 undecylenic acid?
18 other medicines are given the same way (topical) and in the same FDA class as undecylenic acid or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 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 |
|---|---|---|---|---|
| Tolnaftate | Fungal infections | none listed | $0.119 per gram 1% cream | No current entry |
| Clotrimazole | Fungal infections | 13 labelers | $0.133 per gram 1% topical cream | No current entry |
| Miconazole | Fungal infections | none listed | $0.120 per gram 2% topical cream | No current entry |
| Ketoconazole | Fungal infections | 25 labelers | $0.249 per gram 2% cream | No current entry |
| Selenium sulfide | Fungal infections | 1 labeler | $0.0141 per mL 1% shampoo | No current entry |
| Ciclopirox | Fungal infections | 14 labelers | $0.169 per gram 0.77% cream | No current entry |
| Nystatin and triamcinolone | Fungal infections | 18 labelers | $0.225 per gram Nystatin-triamcinolone cream | No current entry |
| Terbinafine | Fungal infections | 20 labelers | $0.353 per gram 1% cream | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does undecylenic acid compare with medicines for the same use?
2 side-by-side pages set undecylenic acid beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Undecylenic acid side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other