Salonpas

NDA 22029, held by Hisamitsu Pharm Co. Menthol; Methyl Salicylate.

As of Nov 15, 2026, NDA 22029 (Salonpas), held by Hisamitsu Pharm Co, was first approved by FDA on Feb 20, 2008, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 20, 2008
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: arthritis sprains strains bruises simple backache

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Mar 29, 2013	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Pediatric Medical Review Pediatric Medical Review Pediatric Clinical Pharmacology Review
Nov 5, 2012	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 20, 2008	Original applicationTYPE 3/4 · Standard review	Approved	Review Summary Review Letter

Products

2 strengths and forms


Salonpas3%;10% · patch;topical	Menthol; Methyl Salicylate	OTCReference drug
Salonpas3%;10% · patch;topical	Menthol; Methyl Salicylate	OTCReference drug

All 13 submissions, including labeling and manufacturing supplements


Oct 6, 2025	Supplement 20Labeling · Standard review	Approved	Letter Label
Nov 4, 2021	Supplement 19Labeling · Standard review	Approved	Label Letter
Jan 31, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Mar 30, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Jan 31, 2014	Supplement 14Manufacturing · Standard review	Approved	Label Letter
Jun 13, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 29, 2013	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Pediatric Medical Review Pediatric Medical Review Pediatric Clinical Pharmacology Review
Nov 5, 2012	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 6, 2011	Supplement 9Labeling · Standard review	Approved	Letter
Sep 13, 2010	Supplement 7Manufacturing · Standard review	Approved	Letter
Jun 19, 2009	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 25, 2008	Supplement 2Manufacturing	Approved	Letter
Feb 20, 2008	Original applicationTYPE 3/4 · Standard review	Approved	Review Summary Review Letter

Identifiers

Application: NDA 22029
Drugs@FDA: Overview at FDA
Company: Hisamitsu Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters