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 28 of 156 · 3,115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Softlips Naturals Medicated Elderberry Acai CAMPHOR, MENTHOL The Mentholatum Company 4e0743a6-d450-043b-e063-6394a90ad1c2 2026-03-27 Warnings Exact identifier application number: M017 QFSN Pain Relief Cream PAIN RELIEF CREAM Qiaofusheng Pharmaceuticals Co., Ltd. 4d215da1-87f5-d35d-e063-6394a90ac348 2026-03-27 Warnings Exact identifier application number: M017 FlexSport Roll On METHYL SALICYLATE Pharmadel LLC bf8de3da-7628-6112-e053-2995a90a8e16 2026-03-26 Warnings Exact identifier application number: M017 Kofal Original METHYL SALICYLATE Pharmadel LLC 984780fd-496b-150b-e053-2995a90aed77 2026-03-26 Warnings Exact identifier application number: M017 Kofal Fuerte METHYL SALICYLATE Pharmadel LLC 98488a07-eba0-2b4e-e053-2995a90ad6ab 2026-03-26 Warnings Exact identifier application number: M017 Kofal Max Power MENTHOL Pharmadel LLC fe1f1408-b0cb-67a4-e053-6394a90ad609 2026-03-26 Warnings Exact identifier application number: M017 Kofal METHYL SALICYLATE Pharmadel LLC 9cac377d-97bc-f0b7-e053-2a95a90a2e12 2026-03-26 Warnings Exact identifier application number: M017 Milagroso CAMPHOR Pharmadel LLC 12b0401c-84d5-07cd-e063-6394a90a052c 2026-03-26 Warnings Exact identifier application number: M017 Ubredol METHYL SALICYLATE Pharmadel LLC fe96eead-1722-c05d-e053-6394a90a850f 2026-03-26 Warnings Exact identifier application number: M017 Quitch Anit-Ich Healing Body Balm HYDROCORTISONE 1% Mor Ventures Inc 4df38c1a-943b-7ba3-e063-6394a90af88e 2026-03-26 Warnings Exact identifier application number: M017 DZUL PAIN FREEZE INSTANT PAIN RELIEF MENTHOL Caball Sales, Inc. 4df3abcc-17f3-17f2-e063-6294a90afcca 2026-03-26 Warnings Exact identifier application number: M017 Equate Cool and Heat Extra Strength MENTHOL Wal-Mart Stores Inc ca3088a7-e1ec-4e69-80d9-fd0051bde938 2026-03-25 Warnings Exact identifier application number: M017 Ultra Strength Muscle Rub - CVS Health Ultra Strength Muscle Rub CAMPHOR, MENTHOL, METHYL SALICYLATE CVS Pharmacy 2ea95529-ec4b-c2ce-e063-6394a90a0739 2026-03-25 Warnings Exact identifier application number: M017 NUMBING CREAMS MENTHOL LIDOCAINE Yongchun Lihui Trading Co., Ltd. 4dd38cdf-d644-6da0-e063-6294a90afb3d 2026-03-25 Warnings Exact identifier application number: M017 ANTIPHLAMINE L-MENTHOL, L-CAMPHOR, METHYL SALICYLATE Masaem Company 4dd3ab12-6cd3-1060-e063-6394a90a2dec 2026-03-25 Warnings Exact identifier application number: M017 LIDOGUARD LIDOCAINE 4% ViolaCare, Inc. d8b021b6-cf71-4f7e-9d27-92d0982bd34f 2026-03-25 Warnings Exact identifier application number: M017 LactiGo MENTHOL LactiGo, Inc. 4dda6ac4-d849-69a6-e063-6394a90a3c54 2026-03-25 Warnings Exact identifier application number: M017 Alocane Max LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE Quest Products LLC 0a33f9a9-1fdc-7cdf-e063-6294a90adca1 2026-03-25 Warnings Exact identifier application number: M017 EjaGuard LIDOCAINE MOLANSPACE INC 475f64ef-d636-7e87-e063-6294a90ae32f 2026-03-25 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE ProStat First Aid 4e53d29c-ed3c-f481-e063-6294a90a3181 2026-03-25 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