Home NDC 80425-0560 Lidocaine and Menthol
Product NDC 80425-0560
11-digit product format 804250560
Labeler code 80425
Product ID 80425-0560_44840256-4718-a719-e063-6394a90a5a14
Type HUMAN OTC DRUG
Nonproprietary name lidocaine and menthol
Dosage form PATCH
Route TRANSDERMAL
Labeler Advanced Rx of Tennessee, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-12
Substance LIDOCAINE; MENTHOL
Active strength .04; .01 g/g; g/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Lidocaine and Menthol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE .04 g/g MENTHOL .01 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup 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 1249758 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 104 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Capsaicin 0.025% Cream CAPSAICIN 0.025% Puretek Corporation 28f00df0-c416-f17b-e063-6294a90a5570 2025-01-02 Warnings Exact identifier application number: M017 AVON HeXashield Pain Relief for Muscle, Back and Joint Cream CAMPHOR, MENTHOL, METHYL SALICYLATE Tai Guk Pharm. Co., Ltd. 8f29ffd7-48b9-109f-e053-2995a90ab215 2025-01-01 Warnings Exact identifier application number: M017 AVON HeXashield Arthritis Pain Relief Cream Capsaisin CAPSAISIN Tai Guk Pharm. Co., Ltd. 8f286a9d-8765-21b3-e053-2a95a90ae43a 2025-01-01 Warnings Exact identifier application number: M017 AVON HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. 8f2aa11d-d794-6f3e-e053-2995a90a1d9d 2025-01-01 Warnings Exact identifier application number: M017 HeXashield Anti Itch Cream with Healing Aloe HYDROCORTISONE Tai Guk Pharm. Co., Ltd. b9d033f3-4d12-a2c8-e053-2995a90ac7f1 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Pain Relief with Menthol MENTHOL Green Compass, Inc. 0a0c212e-ae5d-8505-e063-6394a90af622 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 0a0b688e-50f1-3eb1-e063-6394a90a7efa 2025-01-01 Warnings Exact identifier application number: M017 Green Compass Reduce Topical Pain CAMPHOR, MENTHOL, METHYL SALICYLATE Green Compass, Inc. 8cb80362-5d24-1ee3-e053-2a95a90afcdf 2025-01-01 Warnings Exact identifier application number: M017 OKeeffes Working Hands Pain Relief Skin Protectant ALLANTOIN, LIDOCAINE HYDROCHLORIDE The Gorilla Glue Company/O'Keeffe's Company 0685da25-c9fa-e1cd-e063-6394a90ae1b3 2025-01-01 Warnings Exact identifier application number: M017 Icy Hot with Lidocaine Pain Relieving LIDOCAINE HCL AND MENTHOL Chattem, Inc. 75b28b06-77ea-4fea-b516-2e8a0dac7037 2025-01-01 Warnings Exact identifier application number: M017 Advanced Seal Barrier plus Pain Relief LIDOCAINE Kericure Inc. 7ac95325-e6e9-4c56-9315-876c00af7c98 2025-01-01 Warnings Exact identifier application number: M017 FixMySkin Healing Balm Fragrance-Free HYDROCORTISONE Lovely Skin, Inc. c12af4c6-2f05-46ec-b901-1a4fcd750180 2024-12-31 Warnings Exact identifier application number: M017 Pain Relieving Cream Lidocaine BENZYL ALCOHOL, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC 039a2036-54b2-cf28-e063-6294a90a8ce6 2024-12-31 Warnings Exact identifier application number: M017 Cold Therapy Pain Relief Walgreens MENTHOL 10.5% WALGREEN COMPANY f1daa68d-1b12-c28a-e053-2995a90a0949 2024-12-31 Warnings Exact identifier application number: M017 Calypxo Pain Relief METHYL SALICYLATE, MENTHOL Advanced Rx of Tennessee, LLC 0b7736df-c7e0-7d00-e063-6294a90aa57e 2024-12-31 Warnings Exact identifier application number: M017 New Terocin METHYL SALICYLATE, CAPSAICIN, AND MENTHOL Advanced Rx Pharmacy of Tennessee, LLC f4bfc4a6-06ef-1f76-e053-2995a90a2b8f 2024-12-31 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE Advanced Rx Pharmacy of Tennessee, LLC 01cb19a4-ce22-144d-e063-6294a90a8aa3 2024-12-31 Warnings Exact identifier application number: M017 Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream LIDOCAINE, MENTHOL Sato Pharmaceutical Co., Ltd. 2251e96b-d050-4ec2-a6b9-6659610885bf 2024-12-30 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Safeway af2e2ef3-0f3f-4592-8081-b6553ade2f5a 2024-12-26 Warnings Exact identifier application number: M017 Comforte Menstrual Cramp Relief Cream MENTHOL PMS4PMS LLC c121537e-3333-4f35-8c77-20086158dff4 2024-12-26 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0560-1 80425056001 30 POUCH in 1 CARTON (80425-0560-1) / 1 PATCH in 1 POUCH / 10 g in 1 PATCH 30 pouch 2026-06-12 No No Current