Over-the-counter medicine
Menthol and methyl salicylate Brand names: Salonpas, Numbing
Menthol and methyl salicylate (Salonpas) is an over-the-counter medicine with an FDA approval on record since 2008. No generic is listed; pharmacies paid $0.0365 per gram (Muscle rub 15%-10% cream) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the menthol and methyl salicylate FDA label on DailyMed (effective March 14, 2025, Hisamitsu Pharmaceutical Co., Inc.); the NDA 22029 record on Drugs@FDA; every menthol and methyl salicylate label on DailyMed.
Highlights of the record
FDA label of March 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTemporarily relieves mild to moderate aches and pains of muscles and joints associated with: strains sprains simple backache arthritis bruises
Forms and strengths
- 3 g/100ml / 10 g/100ml
- 31.5 mg / 105 mg
- 63 mg / 210 mg
Patch; cream.
On the market
- Earliest approval on file
- February 20, 2008 Salonpas, Hisamitsu Pharm Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included; 80 more under the over-the-counter monograph, without an application
- Last listed patent
- January 3, 2030 Salonpas patch; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0365 per gram Muscle rub 15%-10% cream
- 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
- 3,834 through July 30, 2026
What is menthol and methyl salicylate used for?
From the label: indications and usageTemporarily relieves mild to moderate aches and pains of muscles and joints associated with: strains sprains simple backache arthritis bruises
Conditions named in the indications of menthol and methyl salicylate's FDA labels, with every medicine labeled for each:
From other menthol and methyl salicylate labelsPain: USES Provides temporary soothing relief of sore muscles associated with strains and sprains, backaches, lumbago, pain of tendons and/or ligaments as well as arthritic or rheumatic pain
Source: FDA drug label (Salonpas Pain Relief), Hisamitsu Pharmaceutical Co., Inc., effective March 14, 2025 (SPL set acd7ba91-221a-485a-ad1f-dd41ed155656), via openFDA; the full label on DailyMed
Is there a generic for menthol and methyl salicylate (Salonpas)?
No generic menthol and methyl salicylate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Salonpas patch, the last expiring on January 3, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2030 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 menthol and methyl salicylate (Salonpas)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0365 per gram (Muscle rub 15%-10% cream), up 4% from $0.035 on October 8, 2025. 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.
- Muscle rub 15%-10% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Muscle rub 15%-10% cream | Generic | $0.0365 per gram | n/a | +4% |
| Pain relieving 1%-15% cream | Generic | $0.044 per gram | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has menthol and methyl salicylate been recalled?
The FDA's Enforcement Report lists 1 recall naming menthol and 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 menthol and 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 does the menthol and methyl salicylate label say about other medicines?
The menthol and methyl salicylate label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings | The chance is small but higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or … |
| Ibuprofen | warnings | The chance is small but higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or … |
| Naproxen | warnings | The chance is small but higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or … |
Source: FDA drug label (Salonpas Pain Relief), Hisamitsu Pharmaceutical Co., Inc., effective March 14, 2025 (SPL set acd7ba91-221a-485a-ad1f-dd41ed155656), via openFDA; the full label on DailyMed
What do FAERS reports show for menthol and methyl salicylate?
The FDA Adverse Event Reporting System holds 3,834 reports that list menthol and methyl salicylate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 225 are coded as a death and 787 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?
- Menthol and methyl salicylate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other