Salonpas Arthritis Pain

Product NDC
46581-685
11-digit product format
465810685
Labeler code
46581
Product ID
46581-685_cfbc2048-8bec-443b-9b73-d5741e62eb9e
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Methyl Salicylate
Dosage form
PATCH
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Hisamitsu Pharmaceutical Co., Inc.
Application
NDA022029
Marketing category
NDA
Marketing start
2022-11-01
Substance
MENTHOL; METHYL SALICYLATE
Active strength
63; 210 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage46581-685-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage46581-685-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage46581-685-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage46581-685-098af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage46581-685-09834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage46581-685-091332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-03-09 01:35 UTC2022-03N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022029-001SALONPAS3%;10%PATCH / TOPICALRLD, RS2008-02-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N022029-002SALONPAS3%;10%PATCH / TOPICALRLD2012-11-05782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022029-00192331842027-08-01Drug product2016-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022029-00188096152030-01-03Drug product2014-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022029-00292331842027-08-01Drug product2016-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022029-00288096152030-01-03Drug product2014-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022029-00192331842027-08-01Drug product2016-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N022029-00188096152030-01-03Drug product2014-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N022029-00292331842027-08-01Drug product2016-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N022029-00288096152030-01-03Drug product2014-08-19d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Salonpas Arthritis Pain
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL63 mg/1
METHYL SALICYLATE210 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
853146Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6518167-fe32-43b2-b736-ba01ac69c12dAvailable on FDA.report

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

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUMBINGMENTHOLFlexiGo Inc4ce416dd-2430-4648-e063-6294a90ab1992026-03-13WarningsExact identifier
application applno (NDA): 022029
application number: NDA022029
Salonpas Pain ReliefMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acd7ba91-221a-485a-ad1f-dd41ed1556562025-03-14WarningsExact identifier
application applno (NDA): 022029
application number: NDA022029
Salonpas Pain ReliefMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.724bc4d3-0bc1-4275-a23b-4bbc62fbc0d22025-03-14WarningsExact identifier
application applno (NDA): 022029
application number: NDA022029
Salonpas Arthritis PainMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.2e88c933-89e6-4a48-be7a-dc6a36e5c8f82025-03-14WarningsExact identifier
application applno (NDA): 022029
application number: NDA022029
Salonpas Arthritis PainMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.a6518167-fe32-43b2-b736-ba01ac69c12d2024-12-13WarningsExact identifier
application applno (NDA): 022029
application number: NDA022029
ndc (product): 46581-685

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853146menthol 3 % / methyl salicylate 10 % Medicated PatchPSNa6518167-fe32-43b2-b736-ba01ac69c12d2
853146menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCDa6518167-fe32-43b2-b736-ba01ac69c12d2
853146menthol 3 % / methyl salicylate 10 % Medicated PatchSYa6518167-fe32-43b2-b736-ba01ac69c12d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46581-685-09465810685093 POUCH in 1 BOX (46581-685-09) / 3 PATCH in 1 POUCH3 pouch2022-11-010000-00-00NoNoCurrent