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Salonpas Pain Relief
Menthol, Methyl Salicylate · Patch
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| 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 BookCodes 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 | 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: strains sprains simple backache arthritis bruises
Purpose
openFDA Drug LabelingPurpose Topical analgesic
Dosage and Administration
openFDA Drug LabelingDirections 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive ingredients (in each patch) Menthol 3% Methyl salicylate 10% (NSAID : nonsteroidal anti-inflammatory drug)
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.