FDA.reportPublic FDA data

Pain Relief Cream

Product NDC
72425-201
11-digit product format
724250201
Labeler code
72425
Product ID
72425-201_2dc1ae04-b3a3-4425-87f2-08e85ba20339
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
SanaMax Plus LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-12-02
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
1 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72425-201IInactivated by FDA2026-10-05
excluded packagepackage72425-20172425-201-02IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72425-201-02Pain Relief Cream1 in 1 BOXCREAM14
72425-201-02Pain Relief Cream28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72425-201PAIN RELIEF CREAM (MENTHOL) CREAM [SANAMAX PLUS LLC]4Legacy NDC, 2 package rows20250101_fee161dc-5047-4b98-9edc-130facbc731d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416982menthol 1.25 % Topical CreamPSNfee161dc-5047-4b98-9edc-130facbc731d4
416982menthol 12.5 MG/ML Topical CreamSCDfee161dc-5047-4b98-9edc-130facbc731d4
416982menthol 1.25 % Topical CreamSYfee161dc-5047-4b98-9edc-130facbc731d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72425-201-02724250201021 TUBE in 1 BOX (72425-201-02) > 28 g in 1 TUBE1 tube2019-12-020000-00-00NoNoCurrent