FDA.reportPublic FDA data

SALONPAS-HOT CAPSICUM

Product NDC
46581-700
11-digit product format
465810700
Labeler code
46581
Product ID
46581-700_3ce9248f-01ca-4e92-b29a-0654b932a6b7
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Hisamitsu Pharmaceutical Co., Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-11-26
Substance
CAPSICUM
Active strength
.025 g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage46581-70046581-700-01DDiscontinued by firm2026-10-20

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-HOT CAPSICUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSICUM.025 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00UK7646FGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043399Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef5373aa-9857-4d01-95af-2d7716e54ae4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-700-03EA - Each46581-700332a19eb-6010-4c93-b753-8f6c02d8922912020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSICUMACTIVE INGREDIENT00UK7646FGSALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]1
CAPSICUMACTIVE MOIETY00UK7646FGSALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]1
NATURAL LATEX RUBBERINACTIVE INGREDIENT2LQ0UUW8INSALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-700SALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]11Current NDC, Legacy NDC20241205_ef5373aa-9857-4d01-95af-2d7716e54ae4.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 29 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Harry COMFORT ZONE CreamLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAMJiangxi Yudexi Pharmaceutical Co., LTD4d32b89f-72e8-bc93-e063-6394a90a0bc82026-03-17WarningsExact identifier
application number: M017
MiloRod Ultra Muscle Rub Fast-Acting Pain ReliefCAPSAICIN, MENTHOLMilo Rod Import & Export, Inc.c3622dc3-0c05-47c9-b70b-4989467819062026-03-17WarningsExact identifier
application number: M017
Walgreens Burn PadBURN PADWalgreens3f8d7624-cf1e-1992-e063-6294a90a38062026-03-17Boxed warning, WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEMericon Industries8f351b04-8f6d-4353-9100-13a8a80d656a2026-03-17WarningsExact identifier
application number: M017
Shoe Pain ReliefLIDOCAINE HCI 4%Sole Amie0f2ccd5f-b9f4-40fc-b82f-173b0f19bf402026-03-16WarningsExact identifier
application number: M017
CVS Muscle BalmMENTHOL, CAMPHORCVS Health42796fc4-03be-3b02-e063-6394a90af2ab2026-03-16WarningsExact identifier
application number: M017
Crane Safety HydrocortisoneHYDROCORTISONECrane Safety LLC96d9527d-9bf7-ce82-e053-2995a90aff0c2026-03-16WarningsExact identifier
application number: M017
CVS Health Pain Relief FootMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.0f646876-69d0-49db-ade2-2b3eb26dd3992026-03-16WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief Foot CreamMENTHOLWalgreen Co.3bc8ece3-d555-3efb-e063-6394a90a19812026-03-16WarningsExact identifier
application number: M017
RICHTOFIT RAPID ACTIVE LEG AND FOOTMENTHOLRICHTOFIT LIMITED LIABILITY COMPANY4c357696-ca96-e6ad-e063-6294a90aaadb2026-03-16WarningsExact identifier
application number: M017
Xpect Stopain ClinicalMENTHOLCintas Corporation348e6062-b31e-435e-a153-6aa868b50efa2026-03-13WarningsExact identifier
application number: M017
DGH GREASELESS MUSCLE RUB ANALGESICMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEDOLLAR GENERAL225abfe0-ec72-4667-96b2-7657e989672b2026-03-13WarningsExact identifier
application number: M017
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
application number: M017
Keeps Climax DelayLIDOCAINE HYDROCHLORIDECosco International, Inc.3bfd3173-2dac-40a9-aec3-982b1d47d8fa2026-03-12WarningsExact identifier
application number: M017
NanoX Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLC4cc38927-8a8c-2df3-e063-6294a90aa0c12026-03-12WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsExact identifier
application number: M017
CVS Lidocaine Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLCVS Pharmacy48c045ae-56b5-62c2-e063-6394a90aaf442026-03-12WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4cd62cba-075a-7448-e063-6394a90ab48d2026-03-12WarningsExact identifier
application number: M017
Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEKroger Company47cc4b05-a937-4624-bf41-85b8bd7c049e2026-03-12WarningsExact identifier
application number: M017
Lidocaine HCLLIDOCAINE HCLMatthias Therapeutics, LLC4cdb27b5-9178-0328-e063-6394a90a50b52026-03-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043399capsaicin 0.025 % Medicated PatchPSNef5373aa-9857-4d01-95af-2d7716e54ae412
1043399capsaicin 0.00025 MG/MG Medicated PatchSCDef5373aa-9857-4d01-95af-2d7716e54ae412
1043399capsaicin 0.025 % Medicated PatchSYef5373aa-9857-4d01-95af-2d7716e54ae412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46581-700-01465810700011 PATCH in 1 POUCH (46581-700-01) > 4 g in 1 PATCH1 patch1998-11-260000-00-00NoNoCurrent
46581-700-03465810700033 PATCH in 1 POUCH (46581-700-03) / 4 g in 1 PATCH3 patch2018-12-010000-00-00NoNoCurrent