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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact 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