FDA.reportPublic FDA data

Salonpas Pain Relief

Manufacturer
Hisamitsu Pharmaceutical Co., Inc.
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 00:57:12

Label at a glance#

ProductSalonpas Pain Relief
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure11 sections

Indications and uses

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

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:

  • strains
  • sprains
  • simple backache
  • arthritis
  • bruises

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-styrene 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#46581-670-05

for temporary relief of mild to moderate pain

Sore Muscle
Sprains
Backache
Joint Pain
Salonpas

Pain Relief 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

5 PATCHES

2 3/4" X 3 15/16" (7cm X 10cm)

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

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

image of 5-patch box labelimage of 5-patch box label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hisamitsu

FREE SAMPLE

NOT FOR RE-SALE

minty scent

NDC#46581-670-99

for temporary relief of mild to moderate pain

Sore Muscle
Sprains
Backache
Joint Pain
1 Peel the center film.

2 Place on affected area.

3 Slide the film forward.

4 Slide the other film backward.

Salonpas

Pain Relief 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

1 patch

2 3/4" X 3 15/16" (7cm X 10cm)

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

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

Manufactured by

Hisamitsu Pharmacetuical Co., Inc.

JAPAN SAGA TOSU

MADE IN JAPAN

Disributed by

Hisamitsu America, Inc.

Florham Park, NJ 07932

image of 1-patch sample pouch labelimage of 1-patch sample pouch label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hisamitsu

NDC#46581-670-06

for temporary relief of mild to moderate pain

Sore Muscle
Sprains
Backache
Joint Pain
BONUS PACK!

ONE FREE PATCH

Salonpas

Pain Relief 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

6 patches

2 3/4" X 3 15/16" (7cm X 10cm)

Package not child resistant.

Keep out of reach of children.

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

image of 6-patch bonus box labelimage of 6-patch bonus box label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853146menthol 3 % / methyl salicylate 10 % Medicated PatchPSN17
853146menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD17
853146menthol 3 % / methyl salicylate 10 % Medicated PatchSY17

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46581-670-012025-03-13C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-032025-03-13C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-052025-03-13C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-062025-03-13C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-152025-03-13C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-202025-03-13C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-992025-03-13C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-012025-01-30C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-032025-01-30C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-052025-01-30C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-062025-01-30C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-152025-01-30C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-202025-01-30C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
46581-670-992025-01-30C16284748780-12cef2736-7d22-d83d-e063-dadaa90ab31f724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-670SALONPAS PAIN RELIEF (MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]17Current NDC, Legacy NDC20250316_724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-670-05EA - Each46581-6701955154e-ed03-4725-aeba-f9b2fdf51bab12015-10-02
46581-670-20EA - Each46581-670122c63a4-340f-4e7e-8304-bec6562569e912022-11-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A13
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y13
MENTHOLACTIVE MOIETYL7T10EIP3A13
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ13
ALUMINUM SILICATEINACTIVE INGREDIENTT1FAD4SS2M13
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP13

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
46581-67046581-670-15, 46581-670-20, 46581-670-06, 46581-670-05, 46581-670-03, 46581-670-01, 46581-670-99

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
ALUMINUM SILICATET1FAD4SS2MIACT
MINERAL OILT5L8T28FGPIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 112 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
ALUMINUM SILICATEALUMINUM SILICATET1FAD4SS2MSYSTEM / TOPICAL19 mgExact identifier — unii+route
8 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii+route
104 equally ranked IID candidates
ALUMINUM SILICATEALUMINUM SILICATET1FAD4SS2MSYSTEM / TOPICAL19 mgExact identifier — unii+route
8 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii+route
104 equally ranked IID candidates
ALUMINUM SILICATEALUMINUM SILICATET1FAD4SS2MSYSTEM / TOPICAL19 mgExact identifier — unii+route
8 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
ALUMINUM SILICATEALUMINUM SILICATET1FAD4SS2MSYSTEM / TOPICAL19 mgExact identifier — unii+route
8 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii+route
104 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii+route
104 equally ranked IID candidates

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 Pain ReliefMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.724bc4d3-0bc1-4275-a23b-4bbc62fbc0d22025-03-14WarningsExact identifier
ndc (package): 46581-670-03
ndc (package): 46581-670-06
ndc (package): 46581-670-15
ndc (package): 46581-670-05
ndc (package): 46581-670-01
ndc (package): 46581-670-99
ndc (package): 46581-670-20
ndc (product): 46581-670
ndc11 (package): 46581067005
ndc11 (package): 46581067020
ndc11 (package): 46581067099
ndc11 (package): 46581067015
ndc11 (package): 46581067001
ndc11 (package): 46581067006
ndc11 (package): 46581067003
spl id: b15d7bd2-d065-4a54-af88-27518cc59143
spl set id: 724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2

Reported adverse events (FAERS/openFDA)#

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