FDA.reportPublic FDA data

Mentholatum Deep Heating Rub

Manufacturer
The Mentholatum Company
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:43:40

Label at a glance#

ProductMentholatum Deep Heating Rub Extra Strength
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints due to arthritis strains simple backache sprains

Dosage and administration

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 8%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Menthol - External analgesic

Methyl salicylate - External analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints due to

  • arthritis
  • strains
  • simple backache
  • sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not get into eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, other heat sources, or right after a shower/bath
  • do not use in combination with other external analgesic products

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • excessive irritation, burning, or discomfort of the skin develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a healthcare 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 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

glyceryl stearate, isoceteh-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Questions?

OTC - QUESTIONS SECTION

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

www.mentholatum.com

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Deep Heating PDP
Deep Heating PDP

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311511menthol 8 % / methyl salicylate 30 % Topical CreamPSN9
311511menthol 80 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD9
311511menthol 8 % / methyl salicylate 30 % Topical CreamSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-2002-42023-02-07C16284748780-1f386c649-9e7e-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Deep Heating Rub
10742-2002-42023-01-30C16284748780-1f386c649-9e7e-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Deep Heating Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-2002-4Mentholatum Deep Heating RubExtra Strength57 g in 1 TUBECREAM579
10742-2002-4Mentholatum Deep Heating RubExtra Strength2 in 1 CARTONCREAM29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-2002MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH (MENTHOL, METHYL SALICYLATE) CREAM [THE MENTHOLATUM COMPANY]9Current NDC, Legacy NDC, 2 package rows20241215_f5684158-0d83-4031-b493-5422ddc73e78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2
MENTHOLACTIVE MOIETYL7T10EIP3A2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M22
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM02
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-200210742-2002-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOCETETH-20O020065R7ZIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
TROLAMINE9O3K93S3TKIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CREAM / TOPICAL13 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
QUATERNIUM-15QUATERNIUM-15E40U03LEM0CREAM / TOPICAL0.02 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2CREAM / TOPICAL13 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii+route+dosage form
2 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
Mentholatum Deep Heating Rub Extra StrengthMENTHOL, METHYL SALICYLATEThe Mentholatum Companyf5684158-0d83-4031-b493-5422ddc73e782024-12-13WarningsExact identifier
ndc (package): 10742-2002-4
ndc (product): 10742-2002
ndc11 (package): 10742200204
spl id: 292c797e-751e-ede6-e063-6394a90ae287
spl set id: f5684158-0d83-4031-b493-5422ddc73e78

Reported adverse events (FAERS/openFDA)#

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