cold hot patch

Product NDC
62379-001
11-digit product format
623790001
Labeler code
62379
Product ID
62379-001_0fc7f516-d1ee-258c-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Simple Diagnostics, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-02-23
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct62379-001IInactivated by FDA2026-08-11
excluded packagepackage62379-00162379-001-35IInactivated by FDA2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62379-001-35IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62379-001-35IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62379-001-35IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62379-001-35IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62379-001-35IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62379-001-35IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62379-001-35IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62379-001-35IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62379-001-35IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62379-001-35IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62379-001-35IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62379-001-35IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage62379-001-35IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage62379-001-35IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage62379-001-35IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage62379-001-35IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage62379-001-35IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage62379-001-35IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage62379-001-35IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62379-001-35IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage62379-001-35IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage62379-001-35EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62379-001-352020-01-31C16284748780-19d75b9d0-dcf3-f424-e053-dadaa90a57cecold & hot patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62379-001-25cold hot patch.408 g in 1 PATCHPATCH.4081
62379-001-35cold hot patch12 in 1 PACKAGEPATCH121
62379-001-35cold hot patch4 in 1 CARTONPATCH41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
2-ETHYLHEXYL ACRYLATEINACTIVE INGREDIENTHR49R9S6XGCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8SCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0COLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188COLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
POLYACRYLIC ACID (8000 MW)INACTIVE INGREDIENT73861X4K5FCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62379-001COLD HOT PATCH (MENTHOL) PATCH [SIMPLE DIAGNOSTICS, INC.]1Legacy NDC, 3 package rows20150224_0fc7f516-d1ed-258c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN0fc7f516-d1ed-258c-e054-00144ff8d46c1
420222menthol 0.05 MG/MG Medicated PatchSCD0fc7f516-d1ed-258c-e054-00144ff8d46c1
420222menthol 5 % Medicated PatchSY0fc7f516-d1ed-258c-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62379-001-2562379000125.408 g in 1 PATCHHistorical
62379-001-356237900013512 in 1 PACKAGEHistorical