← FDA DRUG APPROVALS

FDA NDA · NDA022029

SALONPAS PAIN RELIEF

menthol, methyl salicylate

Sponsor: HISAMITSU PHARM CO

APPLICATION
NDA022029
TYPE
NDA
ORIGINAL APPROVAL
2008-02-20
LATEST ACTION
2025-10-06
ROUTE
PERCUTANEOUS, TOPICAL, TRANSDERMAL
DOSAGE FORM
PATCH
MARKETING STATUS
Over-the-counter

Products

SALONPAS · ReferenceOver-the-counter
MENTHOL 3%, METHYL SALICYLATE 10% · PATCH · TOPICAL
SALONPAS · ReferenceOver-the-counter
MENTHOL 3%, METHYL SALICYLATE 10% · PATCH · TOPICAL

Approval history

2025-10-06Labeling · Supplement 20 · standard — Letter ↗AP
2021-11-04Labeling · Supplement 19 · standard — Letter ↗AP
2019-01-31Labeling · Supplement 17 · standard — Label ↗AP
2015-03-30Manufacturing (CMC) · Supplement 10 · standardAP
2014-01-31Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2013-06-13Manufacturing (CMC) · Supplement 13 · standardAP
2013-03-29Efficacy · Supplement 12 · standard — Pediatric Medical Review ↗AP
2012-11-05Efficacy · Supplement 11 · standard — Label ↗AP
2011-06-06Labeling · Supplement 9 · standard — Letter ↗AP
2010-09-13Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2009-06-19Labeling · Supplement 3 · standard — Letter ↗AP
2008-08-25Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2008-02-20Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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