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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Salonpas DEEP Relieving
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A, LAV5U5022Y
Rxcui1425325

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

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