Assured Cold N Hot Pain Relief Menthol

Product NDC
33992-6159
11-digit product format
339926159
Labeler code
33992
Product ID
33992-6159_b2bf31ce-d06a-e357-e053-2a95a90a987a
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Greenbrier International, Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-17
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 mg/100mg
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct33992-6159IInactivated by FDA2026-10-12
excluded packagepackage33992-615933992-6159-5IInactivated by FDA2026-10-12

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 packagepackage33992-6159-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33992-6159-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33992-6159-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33992-6159-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33992-6159-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33992-6159-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33992-6159-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33992-6159-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33992-6159-50efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33992-6159-5ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33992-6159-5367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33992-6159-5557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33992-6159-58af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33992-6159-5834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33992-6159-51332a3947898…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
33992-6159-52024-01-30C16284748780-11030e365-4a79-111a-e063-dadaa90a10e2Assured Cold'n Hot Medicated Patch 2ct 6159, 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-6159-5Assured Cold N Hot Pain Relief Menthol5 mg in 1 POUCHPATCH54
33992-6159-5Assured Cold N Hot Pain Relief Menthol2 in 1 PACKETPATCH24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
MENTHOLACTIVE MOIETYL7T10EIP3AASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0ASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
GELATININACTIVE INGREDIENT2G86QN327LASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
KAOLININACTIVE INGREDIENT24H4NWX5COASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621ASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341LASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2
waterINACTIVE INGREDIENT059QF0KO0RASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-6159ASSURED COLD N HOT PAIN RELIEF MENTHOL (MENTHOL) PATCH [GREENBRIER INTERNATIONAL, INC]4Legacy NDC, 2 package rows20201124_21de1eeb-a54e-426d-ac2e-a93a2db860db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN21de1eeb-a54e-426d-ac2e-a93a2db860db4
420222menthol 0.05 MG/MG Medicated PatchSCD21de1eeb-a54e-426d-ac2e-a93a2db860db4
420222menthol 5 % Medicated PatchSY21de1eeb-a54e-426d-ac2e-a93a2db860db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33992-6159-5339926159052 POUCH in 1 PACKET (33992-6159-5) > 5 mg in 1 POUCH2 pouch2014-10-170000-00-00NoNoCurrent