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Salonpas Pain Relief

Menthol, Methyl Salicylate · Patch

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Salonpas Pain Relief
Generic name
Menthol, Methyl Salicylate
Dosage form
Patch
Route
Percutaneous
Marketing category
NDA · NDA
Labeler
Hisamitsu Pharmaceutical Co., Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
2
Packages
10
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Menthol 31.5 mg/1 1947261 View
Menthol 63 mg/1 1947261 View
Methyl Salicylate 105 mg/1 1947261 View
Methyl Salicylate 210 mg/1 1947261 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Patch
Route of administration
Percutaneous
Presentations
12

Regulatory status

Source: Drugs@FDANDC Directory
Application number
022029
Application type
NDA · New Drug Application
Approval date
February 20, 2008
Sponsor
HISAMITSU PHARM CO
Products on application
2
Submissions recorded
13
Products approved under application 022029.
Product Trade name Form Strength Ingredient Status TE Flags
022029-001 SALONPAS PATCH MENTHOL; METHYL SALICYLATE Over-the-counter — RLD RS
022029-002 SALONPAS PATCH MENTHOL; METHYL SALICYLATE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9233184 August 1, 2027 001 No February 11, 2016
9233184 August 1, 2027 002 No February 11, 2016
8809615 January 3, 2030 001 No August 19, 2014
8809615 January 3, 2030 002 No August 19, 2014

Approval history

Source: Drugs@FDA
Most recent submissions on application 022029.
Type No. Action Status Date Review
Supplement 20 Labeling Approved October 6, 2025 Standard
Supplement 19 Labeling Approved November 4, 2021 Standard
Supplement 17 Labeling Approved January 31, 2019 Standard
Supplement 10 Manufacturing (CMC) Approved March 30, 2015 Standard
Supplement 14 Manufacturing (CMC) Approved January 31, 2014 Standard
Supplement 13 Manufacturing (CMC) Approved June 13, 2013 Standard
Supplement 12 Efficacy Approved March 29, 2013 Standard
Supplement 11 Efficacy Approved November 5, 2012 Standard
Supplement 9 Labeling Approved June 6, 2011 Standard
Supplement 7 Manufacturing (CMC) Approved September 13, 2010 Standard
Supplement 3 Labeling Approved June 19, 2009 Standard
Supplement 2 Manufacturing (CMC) Approved August 25, 2008 N/A
Original application 1 Type 3 - New Dosage Form and Type 4 - New Combination Approved February 20, 2008 Standard

Review documents

  • 0 · Supplement · October 7, 2025
  • 0 · Supplement · October 7, 2025
  • 0 · Supplement · November 9, 2021
  • 0 · Supplement · November 5, 2021
  • 0 · Supplement · February 13, 2019
  • 0 · Supplement · February 6, 2019
  • 0 · Supplement · February 14, 2014
  • 0 · Supplement · February 4, 2014
  • 0 · Supplement · January 15, 2014
  • 0 · Supplement · April 1, 2013
  • 0 · Supplement · November 7, 2012
  • 0 · Supplement · June 7, 2011
  • 0 · Supplement · September 15, 2010
  • 0 · Original application · May 3, 2010
  • 0 · Original application · May 3, 2010
  • 0 · Supplement · June 29, 2009
  • 0 · Supplement · June 24, 2009
  • 0 · Supplement · August 25, 2008
  • 0 · Original application · February 26, 2008
  • 0 · Supplement · January 1, 1900
  • 0 · Supplement · January 1, 1900
  • 0 · Supplement · January 1, 1900
  • 0 · Supplement · January 1, 1900

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250314). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250314 HUMAN OTC DRUG · 20250314

Indications and Usage

openFDA Drug Labeling

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

Purpose Topical analgesic

Dosage and Administration

openFDA Drug Labeling

Directions Adults 18 years and older: only use one patch at a time clean and dry affected area remove patch from backing film and apply to skin (see illustration) apply one patch to the affected area and leave in place for up to 8 to 12 hours if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours do not use more than 2 patches per day do not use for more than 3 days in a row the used patch should be removed from the skin when a new one is applied Children under 18 years of age: do not use; this product has not been shown to work in children

Warnings For external use only Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. 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 for a longer time than directed Do not use on the face or rashes on wouds or damaged skin if allergic to aspirin or other NSAIDs with a heating pad when sweating (such as from exercise or heat) any patch from a pouch that has been open for 14 or more days right before or after heart surgery Ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease, or kidney disease When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Do not use on the face or rashes on wouds or damaged skin if allergic to aspirin or other NSAIDs with a heating pad when sweating (such as from exercise or heat) any patch from a pouch that has been open for 14 or more days right before or after heart surgery Ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease, or kidney disease When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you are allergic to topical products the stomach bleeding warning applies to you you are taking a diuretic you have high blood pressure, heart disease, or kidney disease When using this product wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water. the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Stop use and ask a doctor if stomach pain or upset gets worse or lasts you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach beeding. rash, itching or skin irritaion develops condition worsens symptoms last for more than 3 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each patch) Menthol 3% Methyl salicylate 10% (NSAID : nonsteroidal anti-inflammatory drug)

Adverse event reports

Source: openFDA FAERS
54,494
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: MENTHOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
46581-670-01 46581-670 Hisamitsu Pharmaceutical Co., Inc. 1 PATCH in 1 POUCH (46581-670-01) July 6, 2011
46581-670-03 46581-670 Hisamitsu Pharmaceutical Co., Inc. 3 PATCH in 1 POUCH (46581-670-03) September 26, 2008
46581-670-05 46581-670 Hisamitsu Pharmaceutical Co., Inc. 1 POUCH in 1 BOX (46581-670-05) / 5 PATCH in 1 POUCH May 22, 2008
46581-670-06 46581-670 Hisamitsu Pharmaceutical Co., Inc. 2 POUCH in 1 BOX (46581-670-06) / 3 PATCH in 1 POUCH December 31, 2013
46581-670-15 46581-670 Hisamitsu Pharmaceutical Co., Inc. 3 POUCH in 1 BOX (46581-670-15) / 5 PATCH in 1 POUCH June 26, 2008
46581-670-20 46581-670 Hisamitsu Pharmaceutical Co., Inc. 4 POUCH in 1 BOX (46581-670-20) / 5 PATCH in 1 POUCH February 1, 2020
46581-670-99 46581-670 Hisamitsu Pharmaceutical Co., Inc. 1 PATCH in 1 POUCH (46581-670-99) July 6, 2011
46581-675-01 46581-675 Hisamitsu Pharmaceutical Co., Inc. 1 PATCH in 1 POUCH (46581-675-01) August 1, 2020
46581-675-09 46581-675 Hisamitsu Pharmaceutical Co., Inc. 3 POUCH in 1 BOX (46581-675-09) / 3 PATCH in 1 POUCH June 1, 2018
46581-675-99 46581-675 Hisamitsu Pharmaceutical Co., Inc. 1 PATCH in 1 POUCH (46581-675-99) May 15, 2019
46581-670 46581-670 Hisamitsu Pharmaceutical Co., Inc. — April 25, 2008
46581-675 46581-675 Hisamitsu Pharmaceutical Co., Inc. — June 1, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.