Home NDC 76420-145 Zylotrol
Product NDC 76420-145
11-digit product format 764200145
Labeler code 76420
Product ID 76420-145_07cebfba-4f3b-882f-e063-6294a90ac460
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCl 4%, Menthol 1%
Dosage form GEL
Route TOPICAL
Labeler Asclemed USA, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-12
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 4; 1 g/100g; g/100g
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 Zylotrol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100g MENTHOL, UNSPECIFIED FORM 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A 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 1373137 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 76420-145-04 Zylotrol 1 in 1 BOX GEL 1 3 76420-145-04 Zylotrol 118.3 g in 1 TUBE GEL 118.3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-145 ZYLOTROL (LIDOCAINE HCL 4%, MENTHOL 1%) GEL [ASCLEMED USA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20231016_e13984ea-73a9-2894-e053-2995a90a8ed6.zip
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 127 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE Stratus Pharmaceuticals Inc e1a8d4a7-01f7-4bab-8d09-875c461b3b61 2024-09-19 Warnings Exact identifier application number: M017 Camphor Spirit CAMPHOR 10% Strategic Sourcing Services, LLC 2216d799-7f6f-cab7-e063-6294a90a8d6c 2024-09-14 Warnings Exact identifier application number: M017 Meijer Analgesic Lidocaine Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa 2024-09-12 Warnings Exact identifier application number: M017 leader anti itch DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Cardinal Health 110, LLC. dba Leader e1aab35b-80d9-4515-afb7-8c662bc5d028 2024-09-11 Warnings Exact identifier application number: M017 LactiGo MENTHOL LactiGo, Inc. 849c3601-2bc8-0991-e053-2a91aa0a5e7f 2024-09-03 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis MENTHOL 8% Telebrands Corp c22cf1a5-0d5d-5ea5-e053-2995a90a333b 2024-09-02 Warnings Exact identifier application number: M017 Itch and Rash Cream HYDROCORTISONE Wildman Business Group 1f95757d-a434-f02a-e063-6294a90a2d12 2024-09-01 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Wildman Business Group 1fd1a4b3-b6fd-0d4c-e063-6394a90a3680 2024-09-01 Warnings Exact identifier application number: M017 BIOSAVIA External Analgesic Pain Relief CAPSAICIN BIOSAVIA USA, LLC 814aa66b-7719-4a29-a84e-18290367e9c7 2024-08-28 Warnings Exact identifier application number: M017 Careland Plantar Fasciitis Hydrogel Pain Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 0e2f29c2-2e95-4be0-b7e9-f1761a1321a5 2024-08-21 Warnings Exact identifier application number: M017 Careland Max Strength Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 265b8dd7-64a4-4bc2-a91c-26c761c2090b 2024-08-21 Warnings Exact identifier application number: M017 Real Time Pain Relief Maxx Topical Analgesic MENTHOL REAL TIME PRODUCTS, INC f45eb95a-2813-4124-bdb0-54e078a8237d 2024-08-20 Warnings Exact identifier application number: M017 Theracare Lidocaine Pain relief LIDOCAINE Veridian Healthcare 1d8a3679-637d-94c0-e063-6294a90a9ecf 2024-08-19 Warnings Exact identifier application number: M017 LidoSync LIDOCAINE, MENTHOL iON Pharma, LLC 200f883c-439a-3b99-e063-6394a90aed10 2024-08-19 Warnings Exact identifier application number: M017 Eagle Brand Medicated Oil Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 09243a23-1f17-f77b-e063-6394a90a0b22 2024-08-19 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Scalp Relief Anti-itch HYDROCORTISONE CVS Health b5ef0005-8b76-4205-8be0-db3a7ed7d1c4 2024-08-19 Warnings Exact identifier application number: M017 Rite Aid Pain Relieving Roll-On LIDOCAINE HCL Rite Aid Corporation 1406590c-667c-84eb-e063-6294a90a5052 2024-08-16 Warnings Exact identifier application number: M017 Nuvira CAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10% Strand Health Group ff448183-03cf-df2d-e053-6394a90a77f0 2024-08-16 Warnings Exact identifier application number: M017 FLANAX METHYL SALICYLATE, MENTHOL, CAPSAICIN Belmora LLC 5e06c688-a086-4c1c-8dab-fcead61fef40 2024-08-13 Warnings Exact identifier application number: M017 Pain Relief MENTHOL Pain Relieving Spray Inc. 1f44466f-044f-70fe-e063-6294a90ad575 2024-08-09 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 Marketing end Sample Exclude flag Status 76420-145-04 76420014504 1 TUBE in 1 BOX (76420-145-04) / 118.3 g in 1 TUBE 1 tube 2022-06-12 0000-00-00 No No Current