FDA.reportPublic FDA data

MENTHOL

Product NDC
72937-004
11-digit product format
729370004
Labeler code
72937
Product ID
72937-004_44141d2a-1d91-b970-e063-6294a90a53f4
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
SUNSET PAIN RELIEF ROLL-ON 3OZ
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-24
Marketing end
2026-10-23
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
4 g/100mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72937-00472937-004-03DDiscontinued by firm2026-10-23

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
MENTHOL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
934d4638-b47b-187d-e053-2995a90ae69dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72937-004-03MENTHOL90 mL in 1 BOTTLE, WITH APPLICATORGEL904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72937-004MENTHOL GEL [SUNSET PAIN RELIEF ROLL-ON 3OZ]3Current NDC, 1 package rows20240129_934d4638-b47b-187d-e053-2995a90ae69d.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 93 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WaxRx EarAcheRx Pain Relieving Drops4% LIDOCAINE HCLDOCTOR EASY MEDICAL PRODUCTS, LLC34156655-8706-f0a4-e063-6294a90acc902025-05-01WarningsExact identifier
application number: M017
foster and thrive anti itch creamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEStrategic Sourcing Services LLCbb08293d-5db8-4cc8-9fe3-bd02061dbeb92025-04-30WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINESolis Pharmaceuticals Inc.3061d301-2104-b1b2-e063-6394a90a9b6e2025-04-29WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEInterMed Laboratories Private Limited33ed754e-8852-d5b2-e063-6394a90a7cf22025-04-29WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee6e48-243e-4ded-e063-6394a90a987d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd32b96689-8e9b-4c2e-e063-6294a90a7d1c2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3304e362-dcda-3f5e-e063-6294a90a70152025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2f2f753d-c791-e863-e063-6394a90aec5d2025-04-29WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3162c96a-061d-2971-e063-6394a90a9b742025-04-29WarningsExact identifier
application number: M017
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsExact identifier
application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-onMENTHOLVeridian Healthcare33dae8a8-4197-f276-e063-6294a90aea832025-04-28WarningsExact identifier
application number: M017
HealthWise Roll-on Menthol Pain Relief GelMENTHOLVeridian Healthcare33dbb939-9397-7e70-e063-6294a90ac8f42025-04-28WarningsExact identifier
application number: M017
Stopain Extra Strength GelMENTHOLTroy Manufacturing, Inc.fa1a98bc-c233-410d-a20e-71111c8973722025-04-28WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Medcore LLCb961906c-fe66-466b-af2c-072781fa098b2025-04-28WarningsExact identifier
application number: M017
Walgreens Lidocaine Knee and ElbowLIDOCAINEWalgreen Co.a3fb4c78-1493-4ba4-ae83-502dd825ed672025-04-25WarningsExact identifier
application number: M017
Walgreens Lidocaine BackLIDOCAINEWalgreen Co.e6bfd342-c0db-46b9-b5e6-5acbd860adf12025-04-25WarningsExact identifier
application number: M017
Electrum Numb FoamLIDOCAINE HCIRENU LABORATORIES, LLCc8472932-28b7-9189-e053-2a95a90a44df2025-04-25WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC66a2fd60-1757-45cc-a195-ecb9241dca2a2025-04-24WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.3385cddb-609f-62e8-e063-6294a90add812025-04-24WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8aae0-2606-c7f2-e063-6294a90a9a202025-04-22WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
72937-004-037293700040390 mL in 1 BOTTLE, WITH APPLICATOR90 mlHistorical