Menthol
Active ingredient
Sold as Saint · Medline · Fortify · Zylotrol · Biofreeze
- Drug class
- -
- Availability
- Prescription and OTC
- Routes
- Topical, Oral, Transdermal, Respiratory (Inhalation), Inhalation
- Markets covered
- 3
- Products on record
- 169
- FDA reports (12 mo)
- 3,666
Overview
Plain-language summary, compiled from the cited regulatory records
Menthol is an active ingredient used in various products [1]. Its drug class is not specified in the provided data [1]. Menthol is indicated for use in adults and children 12 years of age and older by rubbing it on the throat and chest [1]. The vapors are intended to reach the nose and mouth [1].
This ingredient is available under several brand names, including Biofreeze and Medline [1]. In the past 12 months, there have been 3,666 adverse event reports associated with products containing menthol [2]. The most frequently reported adverse events include "Drug Ineffective," "Off Label Use," "Nausea," "Fatigue," and "Headache" [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 149 | May 21, 2026 |
| GB United Kingdom | MHRA | 8 | April 24, 2026 |
| CA Canada | Health Canada | 12 | March 22, 2025 |
USUnited States· FDA
149 products
Uses
Uses for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues temporarily protects irritated areas temporarily relieves burning provides temporary relief from skin irritations temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful temporarily protects inflamed perianal skin temporarily relieves the symptoms of perianal skin irritation may provide a cooling sensation
How to take
GBUnited Kingdom· MHRA
8 products
Uses
For the symptomatic relief of productive (chesty) coughs and sore throats.
How to take
CACanada· Health Canada
12 products
12 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Sources & citations
- [1]FDA DailyMed · 006539c9-1982-d6… · revised October 17, 2025 [PDF]
- [2]MHRA (UK) · PL129650026 · revised February 20, 2026
- [3]Health Canada (DPD) · 00800686 · revised March 22, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.