FDA.reportPublic FDA data

CU Pain Away Pain Relief

Product NDC
71304-001
Requested package NDC
71304-001-00
11-digit product format
713040001
Labeler code
71304
Product ID
71304-001_94e0207c-69f8-1f5c-e053-2a95a90a4029
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Canadian Unique Health Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-03-08
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
13 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage71304-00171304-001-00DDiscontinued 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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71304-001-00CU Pain Away Pain Relief50 g in 1 JARCREAM507
71304-001-00CU Pain Away Pain Relief1 in 1 BOXCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71304-001CU PAIN AWAY PAIN RELIEF (MENTHOL) CREAM [CANADIAN UNIQUE HEALTH LTD.]6Legacy NDC, 2 package rows20231229_4a3d65db-a12e-4f50-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416982menthol 1.25 % Topical CreamPSN4a3d65db-a12e-4f50-e054-00144ff8d46c7
416982menthol 12.5 MG/ML Topical CreamSCD4a3d65db-a12e-4f50-e054-00144ff8d46c7
416982menthol 1.25 % Topical CreamSY4a3d65db-a12e-4f50-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71304-001-00713040001001 JAR in 1 BOX (71304-001-00) > 50 g in 1 JAR1 jar2017-03-080000-00-00NoNoCurrent