Dorflex Icy Hot

Product NDC
62168-0086
11-digit product format
621680086
Labeler code
62168
Product ID
62168-0086_04d3ca8f-167f-4870-a6bd-cb7c0d065707
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
0000-00-00
Substance
MENTHOL
Active strength
429 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62168-0086DDiscontinued by firm2026-10-12
excluded packagepackage62168-008662168-0086-6DDiscontinued by firm2026-10-12

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 · 18 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 packagepackage62168-0086-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62168-0086-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62168-0086-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62168-0086-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62168-0086-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62168-0086-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62168-0086-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62168-0086-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62168-0086-60efc9e666f02…f202fb6c5f17…

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 INGREDIENTL7T10EIP3ADORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
MENTHOLACTIVE MOIETYL7T10EIP3ADORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
2-ETHYLHEXYL ACRYLATEINACTIVE INGREDIENTHR49R9S6XGDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8SDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0DORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311DORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188DORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ADORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RDORFLEX ICY HOT FLEXIBLE, SMALL (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, LARGE (MENTHOL) PATCH DORFLEX ICY HOT FLEXIBLE, XL (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62168-0086-562168008605100 POUCH in 1 BOX (62168-0086-5) > 5 PATCH in 1 POUCH100 pouch2017-08-242022-09-30NoNoCurrent
62168-0086-662168008606100 POUCH in 1 BOX (62168-0086-6) > 5 PATCH in 1 POUCH100 pouch2020-09-200000-00-00NoNoCurrent