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 41 of 156 · 3,115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TopCare Pain Relieving Cream LIDOCAINE HCL 4% Topco Associates, LLC 4885a7e6-a127-450a-e063-6294a90a4f91 2026-01-16 Warnings Exact identifier application number: M017 Calmara CALMARA Dynarex Corporation 487393e9-6619-6033-e063-6294a90a68b2 2026-01-16 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT Walgreens 7088092c-3a5f-4fcc-84cc-931d238f7501 2026-01-15 Warnings Exact identifier application number: M017 Itch Relief Gel DIPHENHYDRAMINE HCL Walgreens 487060a7-dff3-4840-b967-ca919f8d0a29 2026-01-15 Warnings Exact identifier application number: M017 Walgreen Itch Relief Gel DIPHENHYDRAMINE HYDROCHLORIDE Walgreens 5aca3297-406f-4165-9895-c58ccffb374f 2026-01-15 Warnings Exact identifier application number: M017 Pain Relieving Patch LIDOCAINE FlexiGo Inc. 4868af2a-c4be-9c68-e063-6394a90a565b 2026-01-15 Warnings Exact identifier application number: M017 Helocaine Cold Sore Fever Blister Treatment TETRACAINE, MINERAL Pagari Life Science Corp. 1b2eae09-5de0-9219-e063-6294a90af046 2026-01-15 Warnings Exact identifier application number: M017 Careland Lidocaine 4 Pain Relieving Gel-Patches LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6ca8382-7ce5-4df9-912e-8a0ac0423116 2026-01-15 Warnings Exact identifier application number: M017 Neuropathy Cream MENTHOL CREAM Owell Naturals Brand, LLC 48739205-627b-41d0-e063-6394a90a3462 2026-01-15 Warnings Exact identifier application number: M017 BLT 1 BENZOCAINE CENTURA PHARMACEUTICALS INC 3eea2171-850b-4045-e054-00144ff8d46c 2026-01-15 Warnings Exact identifier application number: M017 Icy Hot Lidocaine Dry LIDOCAINE, MENTHOL Chattem, Inc. d500a74e-ab93-4919-8665-a89e9d4cad28 2026-01-15 Warnings Exact identifier application number: M017 Cortizone 10 Bug Bite Relief 1% HYDROCORTISONE Chattem, Inc. b21b6c04-8246-4567-98cf-64e8c588e79c 2026-01-15 Warnings Exact identifier application number: M017 Gold Bond Intensive Relief Anti-Itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chattem, Inc. e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f8 2026-01-14 Warnings Exact identifier application number: M017 Cortizone-10 Soothing Aloe Creme HYDROCORTISONE Chattem, Inc. 1a841bf0-9d7b-4566-b442-aa9bcc827846 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Sensitive Skin Creme HYDROCORTISONE Chattem, Inc. b139917c-00bb-4cb3-995d-a6d2f2c295c6 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 for Psoriasis HYDROCORTIZONE Chattem, Inc. fad9eedb-95e1-4e1a-91e5-0bfd077e0cf5 2026-01-14 Warnings Exact identifier application number: M017 Pain Relief Roll On TOPICAL ANALGESIC Eagle Labs Inc 2380a400-062a-4a8d-a594-a2e097219044 2026-01-14 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE 4% AvKARE 70aace2f-47b4-e961-e053-2991aa0a6367 2026-01-14 Warnings Exact identifier application number: M017 JUST CBD - ULTRA RELIEF MENTHOL, CAMPHOR Just Brands LLC 485f355a-4458-67b6-e063-6394a90ab2a0 2026-01-14 Warnings Exact identifier application number: M017 Relief Pain Relieving Cream MENTHOL Corganics, LP 85814fff-35f8-447f-b669-87eaf55e9859 2026-01-14 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