Salonpas Arthritis Pain

Product NDC
46581-680
Requested package NDC
46581-680-03
11-digit product format
465810680
Labeler code
46581
Product ID
46581-680_bcc483db-24c1-40ec-964a-7e97dfe913ee
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
2008-04-25
Substance
MENTHOL; METHYL SALICYLATE
Active strength
31.5; 105 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 · 4 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
MENTHOL31.5 mg/1
METHYL SALICYLATE105 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
2e88c933-89e6-4a48-be7a-dc6a36e5c8f8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-680-05EA - Each46581-680eef1692f-7294-4253-91af-0d24190b479112015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-680SALONPAS ARTHRITIS PAIN (MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]5Current NDC, Legacy NDC20250316_2e88c933-89e6-4a48-be7a-dc6a36e5c8f8.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
ndc (package): 46581-680-03
ndc (product): 46581-680
ndc11 (package): 46581068003
Salonpas Arthritis PainMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.a6518167-fe32-43b2-b736-ba01ac69c12d2024-12-13WarningsExact identifier
application applno (NDA): 022029
application number: NDA022029

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853146menthol 3 % / methyl salicylate 10 % Medicated PatchPSN2e88c933-89e6-4a48-be7a-dc6a36e5c8f85
853146menthol 0.03 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD2e88c933-89e6-4a48-be7a-dc6a36e5c8f85
853146menthol 3 % / methyl salicylate 10 % Medicated PatchSY2e88c933-89e6-4a48-be7a-dc6a36e5c8f85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46581-680-03465810680033 PATCH in 1 POUCH (46581-680-03) 3 patch2008-09-010000-00-00NoNoCurrent