Smart Sense Cold and Hot Extra Strength Medicated

Product NDC
49738-296
11-digit product format
497380296
Labeler code
49738
Product ID
49738-296_b998fd1f-8c57-485f-813b-f1ed1fddd824
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Kmart Corporation
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-06-30
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct49738-296IInactivated by FDA2026-10-05
excluded packagepackage49738-29649738-296-25IInactivated 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 · 42 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 packagepackage49738-296-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49738-296-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49738-296-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49738-296-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49738-296-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49738-296-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49738-296-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49738-296-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49738-296-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49738-296-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49738-296-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49738-296-25557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49738-296-258af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49738-296-25834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49738-296-251332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49738-296-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49738-296-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49738-296-25bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49738-296-258dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49738-296-25e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49738-296-259bebd1f3094a…5416666fcb17…

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
49738-296-252020-01-31C16284748780-19d75b9d0-c24a-f424-e053-dadaa90a57ceDrug Listing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49738-296-25Smart Sense Cold and Hot Extra Strength Medicated1 in 1 CARTONPATCH11
49738-296-25Smart Sense Cold and Hot Extra Strength Medicated5 in 1 POUCHPATCH51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ASMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
MENTHOLACTIVE MOIETYL7T10EIP3ASMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0SMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
GELATININACTIVE INGREDIENT2G86QN327LSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
KAOLININACTIVE INGREDIENT24H4NWX5COSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RSMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49738-296SMART SENSE COLD AND HOT EXTRA STRENGTH MEDICATED (MENTHOL) PATCH [KMART CORPORATION]1Legacy NDC, 2 package rows20130709_3db7f8cc-ae4b-4a4d-992c-c62c4ffb0216.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN3db7f8cc-ae4b-4a4d-992c-c62c4ffb02161
420222menthol 0.05 MG/MG Medicated PatchSCD3db7f8cc-ae4b-4a4d-992c-c62c4ffb02161
420222menthol 5 % Medicated PatchSY3db7f8cc-ae4b-4a4d-992c-c62c4ffb02161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49738-296-25497380296251 in 1 CARTONHistorical