FDA.reportPublic FDA data

MENTHOL, CAMPHOR

Product NDC
72937-310
Requested package NDC
72937-310-08
11-digit product format
729370310
Labeler code
72937
Product ID
72937-310_e8d18294-a4e7-c408-e053-2995a90a5c01
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
CREAM
Route
TOPICAL
Labeler
SUNSET NOVELTIES, INC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-03-04
Marketing end
0000-00-00
Substance
CAMPHOR (NATURAL); MENTHOL
Active strength
3 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage72937-31072937-310-08DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72937-310-08MENTHOL, CAMPHOR226 g in 1 TUBECREAM2269
72937-310-04MENTHOL, CAMPHOR113 g in 1 TUBECREAM1136
72937-310-42MENTHOL, CAMPHOR113 g in 1 TUBECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72937-310MENTHOL, CAMPHOR CREAM [SUNSET NOVELTIES, INC]8Legacy NDC, 1 package rows20240606_bcb8a65b-3b2f-b82f-e053-2a95a90a51af.zip
72937-310MENTHOL, CAMPHOR CREAM [SUNSET NOVELTIES, INC]5Legacy NDC, 1 package rows20240815_bcb887e3-1ea7-48f2-e053-2995a90a4be1.zip
72937-310MENTHOL, CAMPHOR CREAM [SUNSET NOVELTIES, INC]1Legacy NDC, 1 package rows20240208_10cfbfb1-67bb-f29c-e063-6294a90ae0dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72937-310-0872937031008226 g in 1 TUBE (72937-310-08) 226 g2021-03-040000-00-00NoNoCurrent