FDA.reportPublic FDA data

Salonpas DEEP Relieving

Product NDC
55328-900
11-digit product format
553280900
Labeler code
55328
Product ID
55328-900_91461b7c-ddbc-442a-940e-67f9053580f5
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol, Methyl salicylate
Dosage form
GEL
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Hisamitsu America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
3.1; 10; 15 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 DEEP Relieving
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3.1 g/100g
MENTHOL10 g/100g
METHYL SALICYLATE15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
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
1425325Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4ddb2b9-d023-4c8c-9285-93d51f93207dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55328-900-02Salonpas DEEP Relieving78 g in 1 TUBEGEL784
55328-900-02Salonpas DEEP Relieving1 in 1 BOXGEL14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55328-900-02GM - Gram55328-90078b637e9-1b18-4c58-b243-9563c7ab45b612024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETSALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
MENTHOLACTIVE INGREDIENTL7T10EIP3ASALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YSALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETSALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ASALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZSALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZGSALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432SSALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55328-900SALONPAS DEEP RELIEVING (CAMPHOR, MENTHOL, METHYL SALICYLATE) GEL [HISAMITSU AMERICA, INC.]4Current NDC, Legacy NDC, 2 package rows20241205_a4ddb2b9-d023-4c8c-9285-93d51f93207d.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 68 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAINGEL UNGUENTOCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fab525-b0a5-97fb-e063-6394a90aec6c2025-11-06WarningsExact identifier
application number: M017
PAINGEL ROLL-ONMENTHOLNACOR BUSINESS GROUP LLC42fb0bdf-8bbd-bbe3-e063-6294a90a656c2025-11-06WarningsExact identifier
application number: M017
CoolexaCAMPHOR, MENTHOL, METHYL SALICYLATERising Pharma Holdings, Inc.38839f29-d4ce-4684-a3c7-0bb4bf1ad5942025-11-06WarningsExact identifier
application number: M017
ItchZapDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERising Pharma Holdings, Inc.245d0afb-19a8-4cfb-968b-d892b18d5f2c2025-11-06WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINE AND MENTHOLBullet point LLC42c70681-494b-47c9-e063-6394a90a80be2025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLCba6c7e97-d740-484b-8711-55fa7ab157842025-11-04WarningsExact identifier
application number: M017
China-GelMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, Inc.d7c5cb17-f7a2-7f57-e053-2995a90a40f72025-11-04WarningsExact identifier
application number: M017
Aulief Topical Pain RelieverMENTHOL AND CAMOHORChina-Gel, LLC8647dcc3-1dbc-1093-e053-2991aa0a1ab92025-11-04WarningsExact identifier
application number: M017
China-Gel Topical Pain RelieverMENTHOL AND CAMOHOR (SYNTHETIC)China-Gel, LLC254abae9-ef1b-5a90-e054-00144ff88e882025-11-04WarningsExact identifier
application number: M017
Pain Relief Gel-TubeMENTHOLBullet point LLC42c93789-9758-54b7-e063-6394a90ac3982025-11-04WarningsExact identifier
application number: M017
Tattoo careTATTOO CARE CREAMPerfso (HK) Co., Limited42d0f56f-9cb1-8e19-e063-6394a90aa3e02025-11-04WarningsExact identifier
application number: M017
CORE RELIEFCAMPHOR, MENTHOLCopper Joint, LLC42d17270-f58d-9d69-e063-6294a90a40782025-11-04WarningsExact identifier
application number: M017
Lidocaine and MentholLIDOCAINE AND MENTHOLMarcella Healthd25f25ee-79f8-49e7-9715-0aae305b73e52025-11-03WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINE 5%YYBA Corp1319ee69-8b3f-5815-e063-6294a90a5ad52025-11-03WarningsExact identifier
application number: M017
Goodsense Extra Strength Cold and Hot MedicatedMENTHOLGeiss, Destin and Dunn, Inc.7585d111-775f-4fb6-a485-28cd99d888522025-10-31WarningsExact identifier
application number: M017
Topcare Cold and Hot MedicatedMENTHOLTopco Associates LLC8739aedd-165c-5ae0-e053-2a91aa0afcd02025-10-31WarningsExact identifier
application number: M017
CVS Medicated Heat 1 ctCAPSAICINCVS Pharmacy, Inc.d41dce5b-e698-4930-8869-040b2a973f252025-10-31WarningsExact identifier
application number: M017
Coralite Medicated HeatCAPSAICINUnited Exchange Corp.a0b89c7e-80bc-43c4-840c-5fd567f60b212025-10-31WarningsExact identifier
application number: M017
Dragon with Arnical Pain ReliefMENTHOLGenomma Lab USA Inc.b4cbb7b6-cb71-9721-e053-2995a90a2b2c2025-10-31WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1425325camphor 3.1 % / menthol 10 % / methyl salicylate 15 % Topical GelPSNa4ddb2b9-d023-4c8c-9285-93d51f93207d4
1425325camphor 0.031 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.15 MG/MG Topical GelSCDa4ddb2b9-d023-4c8c-9285-93d51f93207d4
1425325camphor 3.1 % / menthol 10 % / methyl salicylate 15 % Topical GelSYa4ddb2b9-d023-4c8c-9285-93d51f93207d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55328-900-02553280900021 TUBE in 1 BOX (55328-900-02) / 78 g in 1 TUBE1 tube2013-06-010000-00-00NoNoCurrent