Salonpas Arthritis Pain

Manufacturer
Hisamitsu Pharmaceutical Co., Inc.
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:27

Label at a glance#

ProductSalonpas Arthritis Pain
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

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

Dosage and administration

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 ...

Storage and handling

store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit) avoid storing product in direct sunlight protect product from excessive moisture some individuals may not experience pain relief until several hours after applying the patch

Label contents#

Full prescribing information#

Active ingredients (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%

Methyl salicylate 10% (NSAID : nonsteroidal anti-inflammatory drug)

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

  • arthritis
  • sprains
  • strains
  • bruises
  • simple backache

Warnings

WARNINGS SECTION

For external use only

Stomach bleeding warning:

USER SAFETY WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • some individuals may not experience pain relief until several hours after applying the patch

Inactive inredients

INACTIVE INGREDIENT SECTION

alicyclic saturated hydrocarbon resin, baking cloth, film, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-sryrene block copolymer, synthetic aluminum silicate

Questions or comments?

OTC - QUESTIONS SECTION

Toll free 1-87-SALONPAS www.salonpas.us

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hisamitsu

NDC#46581-685-09

LARGE
3 15/16" X 5 1/2"

for temporary relief of mild to moderate pain

Arthritis
Joint Pain
Sprains
Strains

Salonpas
Arthritis Pain Patch

APPLY FOR 8-12 HOURS

Menthol 3%
Methyl Salicylate 10%

Topical Analgesic

FDA APPROVED NON-PRESCRIPTION PAIN RELIEVING PATCH
EFFECTIVENESS CONFIRMED IN CLINICAL TRIAL

9 pathces

3 15/16" X 5 1/2"(10cm X 14cm)

Package not child resistant.
Keep our of reach of children.

* DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.

image of 9-patch box labelimage of 9-patch box label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853146menthol 3 % / methyl salicylate 10 % Medicated PatchPSN2
853146menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD2
853146menthol 3 % / methyl salicylate 10 % Medicated PatchSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46581-685-092024-12-13C16284748780-11030e365-4191-111a-e063-dadaa90a10e2a6518167-fe32-43b2-b736-ba01ac69c12d
46581-685-092024-01-30C16284748780-11030e365-4191-111a-e063-dadaa90a10e2a6518167-fe32-43b2-b736-ba01ac69c12d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46581-685-09Salonpas Arthritis Pain3 in 1 POUCHPATCH32
46581-685-09Salonpas Arthritis Pain3 in 1 BOXPATCH32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-685SALONPAS ARTHRITIS PAIN (MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2Current NDC, Legacy NDC, 2 package rows20241215_a6518167-fe32-43b2-b736-ba01ac69c12d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46581-68546581-685-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022029-001SALONPASMENTHOL; METHYL SALICYLATE3%;10%PATCH / TOPICALRLD, RS2008-02-20
N022029-002SALONPASMENTHOL; METHYL SALICYLATE3%;10%PATCH / TOPICALRLD, RS2012-11-05

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022029-00192331842027-08-01Drug product2016-02-11
N022029-00188096152030-01-03Drug product2014-08-19
N022029-00292331842027-08-01Drug product2016-02-11
N022029-00288096152030-01-03Drug product2014-08-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N022029-002SALONPAS3%;10%PATCH / TOPICALRLD, RS2012-11-0584e616aacf4f…
2026-08-18 06:07:402026-07N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N022029-002SALONPAS3%;10%PATCH / TOPICALRLD, RS2012-11-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-0574a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022029-00192331842027-08-01Drug product2016-02-1184e616aacf4f…
2026-09-14 22:38:342026-08N022029-00188096152030-01-03Drug product2014-08-1984e616aacf4f…
2026-09-14 22:38:342026-08N022029-00292331842027-08-01Drug product2016-02-1184e616aacf4f…
2026-09-14 22:38:342026-08N022029-00288096152030-01-03Drug product2014-08-1984e616aacf4f…
2026-08-18 06:07:402026-07N022029-00192331842027-08-01Drug product2016-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07N022029-00188096152030-01-03Drug product2014-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07N022029-00292331842027-08-01Drug product2016-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07N022029-00288096152030-01-03Drug product2014-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022029-00192331842027-08-01Drug product2016-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022029-00188096152030-01-03Drug product2014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022029-00292331842027-08-01Drug product2016-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022029-00288096152030-01-03Drug product2014-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022029-00192331842027-08-01Drug product2016-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022029-00188096152030-01-03Drug product2014-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022029-00292331842027-08-01Drug product2016-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022029-00288096152030-01-03Drug product2014-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022029-00192331842027-08-01Drug product2016-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022029-00188096152030-01-03Drug product2014-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022029-00292331842027-08-01Drug product2016-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022029-00288096152030-01-03Drug product2014-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022029-00192331842027-08-01Drug product2016-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022029-00188096152030-01-03Drug product2014-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022029-00292331842027-08-01Drug product2016-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022029-00288096152030-01-03Drug product2014-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022029-00192331842027-08-01Drug product2016-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022029-00188096152030-01-03Drug product2014-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022029-00292331842027-08-01Drug product2016-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022029-00288096152030-01-03Drug product2014-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022029-00192331842027-08-01Drug product2016-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022029-00188096152030-01-03Drug product2014-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022029-00292331842027-08-01Drug product2016-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022029-00288096152030-01-03Drug product2014-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022029-00192331842027-08-01Drug product2016-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022029-00188096152030-01-03Drug product2014-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022029-00292331842027-08-01Drug product2016-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022029-00288096152030-01-03Drug product2014-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022029-00192331842027-08-01Drug product2016-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022029-00188096152030-01-03Drug product2014-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022029-00292331842027-08-01Drug product2016-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022029-00288096152030-01-03Drug product2014-08-195bbf6a4d5a75…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salonpas Arthritis PainMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.a6518167-fe32-43b2-b736-ba01ac69c12d2024-12-13WarningsExact identifier
ndc (package): 46581-685-09
ndc (product): 46581-685
ndc11 (package): 46581068509
spl id: cfbc2048-8bec-443b-9b73-d5741e62eb9e
spl set id: a6518167-fe32-43b2-b736-ba01ac69c12d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.