Cold and Hot Pain Relief

Product NDC
67510-0030
11-digit product format
675100030
Labeler code
67510
Product ID
67510-0030_e2214d13-359d-fd08-e053-2995a90af28f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Kareway Product, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-09-12
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
400 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67510-0030DDiscontinued by firm2026-10-15
excluded packagepackage67510-003067510-0030-2DDiscontinued by firm2026-10-15
excluded packagepackage67510-003067510-0030-3DDiscontinued by firm2026-10-15
excluded packagepackage67510-003067510-0030-4DDiscontinued by firm2026-10-15
excluded packagepackage67510-003067510-0030-5DDiscontinued by firm2026-10-15
excluded packagepackage67510-003067510-0030-6DDiscontinued by firm2026-10-15

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 2 · 96 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 packagepackage67510-0030-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0030-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0030-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0030-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67510-0030-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0030-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0030-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0030-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0030-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67510-0030-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0030-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0030-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0030-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0030-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67510-0030-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0030-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0030-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0030-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0030-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67510-0030-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0030-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0030-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0030-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0030-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67510-0030-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0030-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0030-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0030-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0030-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67510-0030-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0030-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0030-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0030-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0030-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67510-0030-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0030-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0030-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0030-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0030-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67510-0030-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0030-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0030-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0030-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0030-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67510-0030-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0030-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0030-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0030-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0030-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67510-0030-4ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ACOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
MENTHOLACTIVE MOIETYL7T10EIP3ACOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6COLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND HOT PAIN RELIEF (MENTHOL) PATCH [KAREWAY PRODUCT, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0030-2675100030021 POUCH in 1 CARTON (67510-0030-2) > 2 PATCH in 1 POUCH1 pouch2011-09-120000-00-00NoNoCurrent
67510-0030-3675100030031 POUCH in 1 CARTON (67510-0030-3) > 3 PATCH in 1 POUCH1 pouch2011-09-120000-00-00NoNoCurrent
67510-0030-4675100030041 POUCH in 1 CARTON (67510-0030-4) > 4 PATCH in 1 POUCH1 pouch2011-09-120000-00-00NoNoCurrent
67510-0030-5675100030051 POUCH in 1 CARTON (67510-0030-5) > 5 PATCH in 1 POUCH1 pouch2016-09-120000-00-00NoNoCurrent
67510-0030-6675100030061 POUCH in 1 CARTON (67510-0030-6) > 6 PATCH in 1 POUCH1 pouch2016-09-120000-00-00NoNoCurrent