FDA.reportPublic FDA data

WellPatch Cooling Pain Relief

Product NDC
10742-8125
11-digit product format
107428125
Labeler code
10742
Product ID
10742-8125_73f7f931-5f31-414c-b5aa-251b6294133b
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
The Mentholatum Company
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-02-06
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct10742-8125DDiscontinued by firm2026-10-05
excluded packagepackage10742-812510742-8125-1DDiscontinued 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8125-12023-02-07C16284748780-1f386c649-be81-0266-e053-dadaa90a7c1aDrug Facts
10742-8125-12023-01-30C16284748780-1f386c649-be81-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8125-1WellPatch Cooling Pain Relief1 in 1 POUCHPATCH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8125WELLPATCH COOLING PAIN RELIEF (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]4Legacy NDC, 1 package rows20241219_13565b05-ce32-444c-8765-cda23b0036fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN13565b05-ce32-444c-8765-cda23b0036fc4
1232426WellPatch Backache Relief 5 % Medicated PatchPSN13565b05-ce32-444c-8765-cda23b0036fc4
1232426menthol 0.05 MG/MG Medicated Patch [Wellpatch Backache Relief]SBD13565b05-ce32-444c-8765-cda23b0036fc4
420222menthol 0.05 MG/MG Medicated PatchSCD13565b05-ce32-444c-8765-cda23b0036fc4
420222menthol 5 % Medicated PatchSY13565b05-ce32-444c-8765-cda23b0036fc4
1232426Wellpatch Backache Relief 5 % Medicated PatchSY13565b05-ce32-444c-8765-cda23b0036fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8125-1107428125011 PATCH in 1 POUCH (10742-8125-1) 1 patch2017-02-060000-00-00NoNoCurrent