FDA.reportPublic FDA data

Salonpas DEEP Relieving

Manufacturer
Hisamitsu America, Inc.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:16

Label at a glance#

ProductSalonpas DEEP Relieving
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with: simple backache sprains strains arthritis bruises

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area apply a dime sized portion to the affected area massage thoroughly until absorbed into skin apply to affected area not more than 3 to 4 times daily Children under 12 years of age: consult a doctor

Storage and handling

Avoid storing product in direct sunlight Protect product from excessive moisture Store at 20-25C (68-77F) Store with lid closed tightly

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.1%

Menthol 10.0%

Methyl salicylate 15.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • sprains
  • strains
  • arthritis
  • bruises

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

OTC - ASK DOCTOR SECTION

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsen
  • skin reactions such are redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • clean and dry affected area
  • apply a dime sized portion to the affected area
  • massage thoroughly until absorbed into skin
  • apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store at 20-25C (68-77F)
  • Store with lid closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium acryloyldimethyltaurate/VP copolymer, dimethyl isosorbide, propylene glycol, SD alcohol 40-B, water

Questions or comments?

OTC - QUESTIONS SECTION

Toll free 1-800-826-8861

www.salonpas.us

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hisamitsu

Non-Greasy Gel

Salonpas DEEP Relieving Gel

TOPICAL ANALGESIC

3 Powerful Pain Fighting Ingredients
Fast-Acting
Fast-Absorbing
MADE IN USA

2.75 OZ (78 g)

image of 78g box labelimage of 78g box label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1425325camphor 3.1 % / menthol 10 % / methyl salicylate 15 % Topical GelPSN4
1425325camphor 0.031 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.15 MG/MG Topical GelSCD4
1425325camphor 3.1 % / menthol 10 % / methyl salicylate 15 % Topical GelSY4

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 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 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
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
MENTHOLACTIVE MOIETYL7T10EIP3A2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERINACTIVE INGREDIENTW59H9296ZG2
DIMETHYL ISOSORBIDEINACTIVE INGREDIENTSA6A6V432S2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55328-90055328-900-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIMETHYL ISOSORBIDEDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii+route
4 equally ranked IID candidates
DIMETHYL ISOSORBIDEDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii+route
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
DIMETHYL ISOSORBIDEDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii+route
4 equally ranked IID candidates
DIMETHYL ISOSORBIDEDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii+route
4 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salonpas DEEP RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu America, Inc.a4ddb2b9-d023-4c8c-9285-93d51f93207d2024-12-03WarningsExact identifier
ndc (package): 55328-900-02
ndc (product): 55328-900
ndc11 (package): 55328090002
spl id: 91461b7c-ddbc-442a-940e-67f9053580f5
spl set id: a4ddb2b9-d023-4c8c-9285-93d51f93207d

Reported adverse events (FAERS/openFDA)#

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