Over-the-counter medicine
Methyl salicylate
Methyl salicylate 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 methyl salicylate FDA label on DailyMed (effective July 10, 2026); every methyl salicylate label on DailyMed.
Highlights of the record
FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageUses for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises and sprains provides penetrating pain relief provides warming pain relief
Forms and strengths
- 1 g
- 10 g
- 25 g
- 10 mg
- 100 mg
- 0.25 g/g
- 1 mg/g
- 10 g/100g
- 10.5 g/100g
- 12 g/100g
- 15 g/100g
- 15.75 g/150g
Cream; ointment; patch; oil; liquid.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 25 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
- 228 through July 30, 2026
What is methyl salicylate used for?
From the label: indications and usageUses for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, bruises and sprains provides penetrating pain relief provides warming pain relief
Conditions named in the indications of methyl salicylate's FDA labels, with every medicine labeled for each:
From other methyl salicylate labelsPain: Uses For the temporary relief of pain
Source: FDA drug label (AVON Foot Works Arthritis Achy Foot and Muscle), COSMAX USA, CORPORATION, effective July 10, 2026 (SPL set 56440d3f-bc93-cebb-e063-6294a90a5f79), via openFDA; the full label on DailyMed
Is there a generic for methyl salicylate?
No generic methyl salicylate is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has methyl salicylate been recalled?
The FDA's Enforcement Report lists 1 recall naming methyl salicylate since 2025: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of methyl salicylate 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 |
|---|---|---|---|
| April 24, 2025 | Class II | KENIL HEALTHCARE PRIVATE LIMITED not a listed maker | CGMP Deviations |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for methyl salicylate?
The FDA Adverse Event Reporting System holds 228 reports that list methyl salicylate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17 are coded as a death and 102 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 methyl salicylate?
13 other medicines are given the same way (topical) and in the same FDA class as methyl salicylate or labeled mainly for the same use (pain), the same class first. Pain lists all 80 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 |
|---|---|---|---|---|
| Lidocaine | Pain | 56 labelers | $0.154 per gram 5% ointment | In shortage |
| Menthol | Pain | none listed | $0.0557 per mL 4% gel | No current entry |
| Diclofenac | Pain | 103 labelers | $0.0813 per gram 1% gel | A presentation being discontinued |
| Bacitracin and neomycin and polymyxin b | Pain | none listed | $0.111 per gram Triple antibiotic ointment | No current entry |
| Capsaicin | Pain | none listed | $0.207 per gram 0.1% cream | No current entry |
| Benzocaine | Pain | none listed | n/a | No current entry |
| Witch hazel | Pain | none listed | $0.0435 per unit 50% pad | No current entry |
| Camphor | Pain | none listed | $0.048 per mL Camphor spirit | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does methyl salicylate compare with medicines for the same use?
5 side-by-side pages set methyl salicylate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Methyl salicylate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other