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 82 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aruba Aloe AlcoholadaLIDOCAINE HYDROCHLORIDEAruba Aloe Balm NVf56c62b0-75db-4499-858e-54e10b0e140a2025-08-07WarningsExact identifier
application number: M017
SurviveX Hydrocortisone CreamHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.3bd1da8d-5142-798c-e063-6294a90a7be62025-08-07WarningsExact identifier
application number: M017
Arthcal SOOTHING PAIN RELIEF MASSAGESOOTHING PAIN RELIEF MASSAGEBeijing JUNGE Technology Co., Ltd.3524ad62-0ed6-f2e5-e063-6394a90a32832025-08-06WarningsExact identifier
application number: M017
Alumier MD Intensive RecoveryHYDROCORTISONEAlumier Labsd9b79ea1-6558-543c-e053-2995a90ae53e2025-08-06WarningsExact identifier
application number: M017
Good Neighbor Roll-on Pain ReliefLIDOCAINE HCLAmerisource Bergena0c3adbf-fa35-47c0-9db3-459ce9a106ac2025-08-06WarningsExact identifier
application number: M017
Good Neighbor Roll-on Menthol Pain Relief GelMENTHOLAmerisource Bergenbd557323-0003-4ee6-b22d-a72d621c7de42025-08-05WarningsExact identifier
application number: M017
Earthmed FS Pain relieving balmMENTHOLEarthmed LLC3ba4e769-fec6-52d9-e063-6394a90a65d42025-08-05WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEHF Acquisition Co LLC, DBA HealthFirst3ba6a5ec-fda2-b2a6-e063-6294a90ac9b62025-08-05WarningsExact identifier
application number: M017
Kocowo Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.3b82989d-7cc3-23d3-e063-6294a90ae2a32025-08-03WarningsExact identifier
application number: M017
Menthol pain relief patchesMENTHOLMenthol pain relief patch3b5fd718-3f86-f7a7-e063-6294a90a8c522025-08-02WarningsExact identifier
application number: M017
Graphene Far Infrared Herbal Pain Relief PatchesCORYDALIS RHIZOMEChangsha Maocheng Trading Co., Ltd3b604a3c-fe91-7096-e063-6394a90afe042025-08-02WarningsExact identifier
application number: M017
Active Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3a9f9ca0-3d8a-796a-e063-6394a90a790c2025-08-01WarningsExact identifier
application number: M017
Active Recovery Pain Relief StickCAMPHOR, MENTHOLCharlottes Web, Inc.3aa037c6-6109-b52e-e063-6394a90a215b2025-08-01WarningsExact identifier
application number: M017
PM Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3aa08859-809d-de8c-e063-6394a90a8e252025-08-01WarningsExact identifier
application number: M017
Wish ultra winter iceMENTHOLLJ Pharmab4c5487c-1314-4d63-96df-077e72e7ee952025-08-01WarningsExact identifier
application number: M017
Rugged Fit Pain Relief Roll OnMENTHOL, METHYL SALICYLATESYSTEM4BOOK LLC39d68734-981c-14d7-e063-6294a90a49192025-08-01WarningsExact identifier
application number: M017
ICY FREEZEMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.28fdb049-b297-4358-9447-7d69ba8797022025-08-01WarningsExact identifier
application number: M017
Cortizone 10 CoolingHYDROCORTISONEChattem, Inc.14d9fce2-9f54-4204-83cb-161de8a303f02025-08-01WarningsExact identifier
application number: M017
Bravado Labs NumbingLIDOCAINE HCLProdigy Media Inc8c43f5b5-b911-4a7a-b2d1-56a09c54b0012025-07-30WarningsExact identifier
application number: M017
Chimera GUARDLIDOCAINE PAIN RELIEFING PATCHHangzhou Rongna Health Technology Co., Ltd.3721c984-1993-6265-e063-6394a90af23f2025-07-29WarningsExact 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