Over-the-counter medicine
Menthol
Menthol is an over-the-counter medicine. No generic is listed; pharmacies paid $0.0424 per unit (Cough drops 5.8 mg) in the October 7, 2026 NADAC survey.
- No generic listed
- Over the counter
Check it at the source: the menthol FDA label on DailyMed (effective April 24, 2024); every menthol label on DailyMed.
Highlights of the record
FDA label of April 24, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetemporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat
Forms and strengths
- 5 g
- 1.1 mg
- 2.5 mg
- 2.7 mg
- 4.8 mg
- 5 mg
- 5.4 mg
- 5.8 mg
- 7.5 mg
- 7.6 mg
- 8.3 mg
- 20 mg
Lozenge; gel; cream; patch; pastille.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 384 of which 0 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0424 per unit Cough drops 5.8 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2022 0 Class I among all firms' recalls; 17 more by firms not listed as its makers
- FAERS reports
- 3,369 through July 30, 2026
What is menthol used for?
From the label: indications and usagetemporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat
Conditions named in the indications of menthol's FDA labels, with every medicine labeled for each:
From other menthol labelsPain: Uses For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations
Cough and cold: Uses Temporarily relieves ■ cough as may occur with a cold or inhaled irritants ■ occasional minor irritation and sore throat
Source: FDA drug label (CHERRY COUGH DROPS 50CT), JHK Inc dba American Safety & First Aid, effective April 24, 2024 (SPL set 2f54b9c1-3a37-48fd-b964-6aa2631b8e62), via openFDA; the full label on DailyMed
Is there a generic for menthol?
No generic menthol is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for menthol?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0424 per unit (Cough drops 5.8 mg), up 17% from $0.0362 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Cough drops 5.8 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Blue 2% gel | Generic | $0.01 per gram | n/a | -11% |
| Cooling pain relief 4% gel | Generic | $0.0557 per mL | n/a | -8% |
| Cough drops 5.4 mg | Generic | $0.034 per unit | n/a | +9% |
| Cough drops 5.8 mg | Generic | $0.0424 per unit | n/a | +17% |
| Cough drops 7.5 mg | Generic | $0.0338 per unit | n/a | +6% |
| Cough drops 7.6 mg | Generic | $0.0435 per unit | n/a | -4% |
| Ft cough drops 5.8 mg | Generic | $0.0424 per unit | n/a | n/a |
| Ft cough drops 7.5 mg | Generic | $0.0338 per unit | n/a | n/a |
| Ft cough drops 7.6 mg | Generic | $0.0435 per unit | n/a | n/a |
| Gnp menthol 4% gel roll-on | Generic | $0.0593 per mL | n/a | n/a |
| Gnp pain relief 5% patch | Generic | $1.02 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +28% |
| Ice blue 2% gel | Generic | $0.01 per gram | n/a | -11% |
| Menthol cold-hot 5% patch | Generic | $1.02 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +28% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has menthol been recalled?
The FDA's Enforcement Report lists 17 recalls naming menthol since 2022: 0 Class I (the most serious), 17 Class II, 0 Class III; 14 still ongoing. 17 of them are by firms that FDA's NDC Directory does not list as a maker of menthol 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 |
|---|---|---|---|
| March 20, 2026 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. not a listed maker | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing … |
| October 24, 2024 | Class II | Unexo Life Sciences Private Limited not a listed maker | cGMP Deviations |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE not a listed maker | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for menthol?
The FDA Adverse Event Reporting System holds 3,369 reports that list menthol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 220 are coded as a death and 747 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
How does menthol compare with medicines for the same use?
7 side-by-side pages set menthol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Menthol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other