Home NDC 62168-0085-3 Dorflex Icy Hot
Product NDC 62168-0085
Requested package NDC 62168-0085-3
11-digit product format 621680085
Labeler code 62168
Product ID 62168-0085_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 206 mg/1
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL ACTIVE INGREDIENT L7T10EIP3A DORFLEX 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 MENTHOL ACTIVE MOIETY L7T10EIP3A DORFLEX 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 ACRYLATE INACTIVE INGREDIENT HR49R9S6XG DORFLEX 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 ACID INACTIVE INGREDIENT J94PBK7X8S DORFLEX 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 HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 DORFLEX 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 SODIUM INACTIVE INGREDIENT K679OBS311 DORFLEX 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 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DORFLEX 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 MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS DORFLEX 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 ACRYLATE INACTIVE INGREDIENT WC487PR91H DORFLEX 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-30 INACTIVE INGREDIENT JJX07DG188 DORFLEX 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 INGREDIENT 9G2MAD7J6W DORFLEX 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 80 INACTIVE INGREDIENT 6OZP39ZG8H DORFLEX 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 INGREDIENT 05I15JNI2J DORFLEX 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 SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A DORFLEX 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, CORN INACTIVE INGREDIENT O8232NY3SJ DORFLEX 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 TALC INACTIVE INGREDIENT 7SEV7J4R1U DORFLEX 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 ACID INACTIVE INGREDIENT W4888I119H DORFLEX 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 DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DORFLEX 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 WATER INACTIVE INGREDIENT 059QF0KO0R DORFLEX 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 NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62168-0085-3 62168008503 270 POUCH in 1 BOX (62168-0085-3) > 5 PATCH in 1 POUCH 270 pouch 2021-04-22 0000-00-00 No No Current