Icy Hot Back

Product NDC
62168-1000
11-digit product format
621681000
Labeler code
62168
Product ID
62168-1000_ec9a2ba8-744f-4a27-a425-408339b80d9b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Lead Chemical Co. Ltd.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-01
Marketing end
2020-05-31
Substance
MENTHOL
Active strength
429 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct62168-1000DDiscontinued by firm2026-10-05
excluded packagepackage62168-100062168-1000-1DDiscontinued by firm2026-10-05

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 · 24 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 packagepackage62168-1000-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62168-1000-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62168-1000-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62168-1000-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62168-1000-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62168-1000-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62168-1000-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62168-1000-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62168-1000-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62168-1000-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62168-1000-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62168-1000-1557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
MENTHOLACTIVE MOIETYL7T10EIP3AICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
2-ETHYLHEXYL ACRYLATEINACTIVE INGREDIENTHR49R9S6XGICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8SICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0ICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188ICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RICY HOT BACK (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1