FDA.reportPublic FDA data

Mentholatum

Manufacturer
The Mentholatum Company
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:42:42

Label at a glance#

ProductMentholatum Original
Active ingredientCAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

temporarily relieves minor aches and pains of muscles and joints

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

Camphor 9%

Menthol 1.3%

Purpose

OTC - PURPOSE SECTION

Camphor - Topical Analgesic

Menthol - Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains of muscles and joints

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not apply to wounds or to damaged skin
  • do not bandage tightly
  • do not heat, microwave, or add to hot water as this may cause splattering and result in burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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

fragrance, petrolatum, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mentholatum Original Ointment
Mentholatum Original Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1042663camphor 9 % / menthol 1.3 % Topical OintmentPSN6
1042667Mentholatum Analgesic Rub 9 % / 1.3 % Topical OintmentPSN6
1042667camphor 0.09 MG/MG / menthol 0.013 MG/MG Topical Ointment [Mentholatum]SBD6
1042663camphor 0.09 MG/MG / menthol 0.013 MG/MG Topical OintmentSCD6
1042663camphor 9 % / menthol 1.3 % Topical OintmentSY6
1042667Mentholatum (camphor 9 % / menthol 1.3 % ) Topical OintmentSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-0002-12023-02-07C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts
10742-0002-22023-02-07C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts
10742-0002-32023-02-07C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts
10742-0002-42023-02-07C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts
10742-0002-12023-01-30C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts
10742-0002-22023-01-30C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts
10742-0002-32023-01-30C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts
10742-0002-42023-01-30C16284748780-1f386c649-bf3c-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-0002-1MentholatumOriginal1 in 1 CARTONOINTMENT16
10742-0002-1MentholatumOriginal28 g in 1 JAROINTMENT286
10742-0002-2MentholatumOriginal1 in 1 CARTONOINTMENT16
10742-0002-2MentholatumOriginal85 g in 1 JAROINTMENT856
10742-0002-3MentholatumOriginal1 in 1 CARTONOINTMENT16
10742-0002-3MentholatumOriginal34 g in 1 JAROINTMENT346
10742-0002-4MentholatumOriginal1 in 1 CARTONOINTMENT16
10742-0002-4MentholatumOriginal102.1 g in 1 JAROINTMENT102.16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-0002MENTHOLATUM ORIGINAL (CAMPHOR, MENTHOL) OINTMENT [THE MENTHOLATUM COMPANY]6Current NDC, Legacy NDC, 8 package rows20241215_19e4b812-67c6-49fd-833a-b432100363f5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
MENTHOLACTIVE MOIETYL7T10EIP3A1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-000210742-0002-1, 10742-0002-2, 10742-0002-3, 10742-0002-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii+route+dosage form
5 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 OriginalCAMPHOR, MENTHOLThe Mentholatum Company19e4b812-67c6-49fd-833a-b432100363f52024-12-13WarningsExact identifier
ndc (package): 10742-0002-2
ndc (package): 10742-0002-4
ndc (package): 10742-0002-3
ndc (package): 10742-0002-1
ndc (product): 10742-0002
ndc11 (package): 10742000204
ndc11 (package): 10742000203
ndc11 (package): 10742000201
ndc11 (package): 10742000202
spl id: 292b4ddf-f5d8-d052-e063-6394a90a5f1d
spl set id: 19e4b812-67c6-49fd-833a-b432100363f5

Reported adverse events (FAERS/openFDA)#

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