FDA.reportPublic FDA data

Salonpas

Product NDC
46581-871
11-digit product format
465810871
Labeler code
46581
Product ID
46581-871_0bd26dcb-64bd-4150-bfb5-a65a17d0cc84
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Hisamitsu Pharmaceutical Co., Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
CAPSAICIN; MENTHOL
Active strength
.025; 1.25 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46581-87146581-871-99DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Salonpas
Brand name suffix
pain relieving hot
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.025 g/100g
MENTHOL1.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
853136Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2aa8820-a947-404b-b617-e692fbd16502Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46581-871-06Salonpaspain relieving hot2 in 1 BOXPATCH210
46581-871-06Salonpaspain relieving hot3 in 1 POUCHPATCH310
46581-871-99Salonpaspain relieving hot1 in 1 POUCHPATCH110
46581-871-99Salonpaspain relieving hot7 g in 1 PATCHPATCH710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-871-06EA - Each46581-871f2503576-4098-4f88-89c3-43eaf65fca8812020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-871SALONPAS PAIN RELIEVING HOT (CAPSAICIN, MENTHOL) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]9Current NDC, Legacy NDC, 4 package rows20241205_d2aa8820-a947-404b-b617-e692fbd16502.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 18 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
application number: M017
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
application number: M017
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
application number: M017
KY Duration for HimLIDOCAINEReckitt Benckiser LLC83cc86bd-3303-4956-a198-fae85b6e34e12026-05-15WarningsExact identifier
application number: M017
4% LIDOCAINE PATCHES4% LIDOCAINEShenzhen Huayuan Hengsheng Technology Co., Ltd.4f53cfd3-a7c4-e308-e063-6294a90ad6982026-05-14WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINETrifecta Pharmaceuticals USA51cb6797-55ec-7a7a-e063-6294a90a90ee2026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnMENTHOLTrifecta Pharmaceuticals USA51b403dc-fc9b-0cad-e063-6394a90af0812026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC684faf63-5e44-4471-8384-e8fa7c0d842a2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
application number: M017
BIOFREEZEMENTHOLReckitt Benckiser LLC83d5c2f2-2413-4d28-83b2-0808d0917b4d2026-05-13WarningsExact identifier
application number: M017
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
853136capsaicin 0.025 % / menthol 1.25 % Medicated PatchPSNd2aa8820-a947-404b-b617-e692fbd1650210
853136capsaicin 0.00025 MG/MG / menthol 0.0125 MG/MG Medicated PatchSCDd2aa8820-a947-404b-b617-e692fbd1650210
853136capsaicin 0.025 % / menthol 1.25 % Medicated PatchSYd2aa8820-a947-404b-b617-e692fbd1650210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46581-871-06465810871062 POUCH in 1 BOX (46581-871-06) / 3 PATCH in 1 POUCH / 7 g in 1 PATCH2 pouch2018-01-010000-00-00NoNoCurrent
46581-871-99465810871991 PATCH in 1 POUCH (46581-871-99) > 7 g in 1 PATCH1 patch2018-11-010000-00-00NoNoCurrent