Cold and Hot Medicated Pain Relief Large

Product NDC
63941-949
11-digit product format
639410949
Labeler code
63941
Product ID
63941-949_838a5a74-d46c-d6d1-e053-2a91aa0aa512
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Valu Merchandisers Company, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-09-12
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
875 mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63941-949IInactivated by FDA2026-10-05
excluded packagepackage63941-94963941-949-05IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63941-949-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63941-949-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63941-949-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63941-949-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63941-949-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63941-949-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63941-949-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63941-949-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63941-949-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63941-949-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63941-949-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63941-949-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63941-949-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63941-949-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63941-949-051332a3947898…d4bfe170f9cd…

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63941-949-052023-07-28C16284748780-10191ceaa-7064-198a-e063-dbdaa90aec3eBest Choice Cold & Hot Large Medicated Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-949-05Cold and Hot Medicated Pain Relief Large5 in 1 POUCHPATCH54
63941-949-05Cold and Hot Medicated Pain Relief Large1 in 1 CARTONPATCH14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8SCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0COLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188COLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-949COLD AND HOT MEDICATED PAIN RELIEF LARGE (MENTHOL) PATCH [VALU MERCHANDISERS COMPANY, INC.]4Legacy NDC, 2 package rows20190308_b7ad84f8-e3e0-47a3-ace2-463ecbdfee3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSNb7ad84f8-e3e0-47a3-ace2-463ecbdfee3e4
420222menthol 0.05 MG/MG Medicated PatchSCDb7ad84f8-e3e0-47a3-ace2-463ecbdfee3e4
420222menthol 5 % Medicated PatchSYb7ad84f8-e3e0-47a3-ace2-463ecbdfee3e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-949-05639410949051 POUCH in 1 CARTON (63941-949-05) > 5 PATCH in 1 POUCH1 pouch2018-12-290000-00-00NoNoCurrent