Home NDC 52000-421 COLD AND HOT MEDICATED LARGE
Product NDC 52000-421
11-digit product format 520000421
Labeler code 52000
Product ID 52000-421_6e490a04-d32f-4dec-9ced-ab55fae6efb1
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form PATCH
Route TOPICAL
Labeler Universal Distribution Center LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-25
Substance MENTHOL, UNSPECIFIED FORM
Active strength .05 g/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base COLD AND HOT MEDICATED LARGE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM .05 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 420222 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52000-421-41 COLD AND HOT MEDICATED LARGE 19 g in 1 PATCH PATCH 19 7 52000-421-41 COLD AND HOT MEDICATED LARGE 1 in 1 POUCH PATCH 1 7 52000-421-42 COLD AND HOT MEDICATED LARGE 1 in 1 POUCH PATCH 1 7 52000-421-42 COLD AND HOT MEDICATED LARGE 24 in 1 BOX PATCH 24 7
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 20 of 156 · 3,115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biofreeze Foot Pain Relief Set MENTHOL Reckitt Benckiser LLC 4a885eef-0364-4655-bccc-7158c76cc5b2 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless Roll-On MENTHOL Reckitt Benckiser LLC a8d59d45-0e85-43d1-affd-bbe922c4acb1 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless MENTHOL Reckitt Benckiser LLC 939dbbc3-71ec-4990-840e-7c9b8d430562 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Flexible Relief Strip MENTHOL Reckitt Benckiser LLC 6ec26bae-e395-49aa-969e-8c653d6f0b27 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Day and Overnight MENTHOL Reckitt Benckiser LLC fb5c8f89-a720-ad32-e053-6294a90a2abe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foam MENTHOL Reckitt Benckiser LLC 890191e8-99ad-489c-8f21-2592f3d31936 2026-05-13 Warnings Exact identifier application number: M017 Orajel Cold Sore Touch Free - Single Dose BENZALKONIUM CHLORIDE, BENZOCAINE Church & Dwight Co., Inc. ce40829e-941f-2548-e053-2995a90a1e0e 2026-05-13 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Patch LIDOCAINE GERI-CARE PHARMACEUTICAL CORP 51b7753b-8619-6ea9-e063-6294a90a4ea4 2026-05-13 Warnings Exact identifier application number: M017 DERMFREE Anti-itch Cream HYDROCORTISONE1% ANTI-ITCH CREAM Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. 519c319a-9c43-0e63-e063-6394a90ab869 2026-05-13 Warnings Exact identifier application number: M017 Valtrum TOPICAL ANALGESIC CAMPHOR, MENTHOL, METHYL SALICYLATE Laboratorios Quantium LLC f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless MENTHOL, UNSPECIFIED FORM Reckitt Benckiser 4639201c-a67a-475f-8df6-3dc6225803ad 2026-05-12 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless Roll-On MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC bae9946a-4c68-4759-9fb3-0a61a7ad0eb7 2026-05-12 Warnings Exact identifier application number: M017 Instaflex Pain Relief Cream MENTHOL Healthy Directions, LLC 665b847a-9cfb-49fc-975b-81c97f936575 2026-05-12 Warnings Exact identifier application number: M017 Theracare Cold Therapy Pain Relief MENTHOL Veridian Healthcare 51a5a043-07b6-1c96-e063-6394a90aa926 2026-05-12 Warnings Exact identifier application number: M017 Stud 100 Male Genital Desensitizer LIDOCAINE Pound International Corp d075656e-b13f-4a1d-bbb6-501e642698d5 2026-05-12 Warnings Exact identifier application number: M017 CeraVe Developed with Dermatologists Itch Relief Moisturizing PRAMOXINE HYDROCHLORIDE L'Oreal USA Products Inc 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86 2026-05-12 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY CVS Pharmacy db6f518d-3a0e-43f8-8d19-7382d9b7ff1c 2026-05-11 Warnings Exact identifier application number: M017 Cool and Heat MENTHOL AMERISOURCE BERGEN f2bb0e8e-c4cd-0e8c-e053-2995a90a6df7 2026-05-11 Warnings Exact identifier application number: M017 Instaflex Extra Strength Pain Relief Cream MENTHOL, METHYL SALICYLATE Healthy Directions, LLC d058c64d-0e4f-45aa-8f52-804961b562e3 2026-05-11 Warnings Exact identifier application number: M017 BonicaEaseX Hot Capsicum Pain Relieving CAPSICUM Planet (Anhui) Pharmaceutical Co.,Ltd ca6e48af-af6d-4808-a576-0319d2080d38 2026-05-11 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52000-421-41 52000042141 1 PATCH in 1 POUCH (52000-421-41) / 19 g in 1 PATCH 1 patch 2024-11-25 No No Current 52000-421-42 52000042142 24 POUCH in 1 BOX (52000-421-42) / 1 PATCH in 1 POUCH / 19 g in 1 PATCH 24 pouch 2024-11-25 No No Current