Home NDC 0363-9654 Walgreens Max Strength Burn Gel
Product NDC 0363-9654
11-digit product format 003639654
Labeler code 0363
Product ID 0363-9654_326d3a8e-cdcd-8da7-e063-6394a90a65a2
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form GEL
Route TOPICAL
Labeler Walgreens Co.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-01
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength 13; 40 mg/mL; mg/mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Walgreens Max Strength Burn Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 13 mg/mL LIDOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup V13007Z41A Internal UNII 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 0363-9654-10 Walgreens Max Strength Burn Gel 1 in 1 CARTON GEL 1 4 0363-9654-10 Walgreens Max Strength Burn Gel 75 mL in 1 TUBE GEL 75 4
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 92 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Isopropyl alcohol 91 percent ISOPROPYL ALCOHOL Jell Pharmaceuticals Pvt. Ltd. cd98812b-017a-2cd2-e053-2a95a90a38ce 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 50% ISOPROPYL ALCOHOL MY IMPORTS LLC d4d72406-067d-1f67-e053-2995a90a1a9f 2024-12-18 Warnings Exact identifier application number: M003 AMORAY 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL MY IMPORT USA INC 7114b527-106b-4629-867c-63dba13635a2 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7e7f8-7c8a-2b51-e053-2995a90a63d0 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL My Imports USA, LLC d4d77ec3-4930-74f0-e053-2a95a90a962a 2024-12-18 Warnings Exact identifier application number: M003 91% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7adaf-c0fd-82fa-e053-2995a90ab9f6 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA, LLC de47bf08-f64e-781d-e053-2a95a90ab08f 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d80ae4-3fba-4605-e053-2a95a90a2119 2024-12-18 Warnings Exact identifier application number: M003 American Red Cross 50% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC de47a879-9cd0-5fbb-e053-2a95a90a1fba 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5ee961-1d64-0d9d-e053-2a95a90a6010 2024-12-18 Warnings Exact identifier application number: M003 70% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL SZY Holdings, LLC dba EverReady First Aid 1e39b0f4-66d1-47ac-aed6-d6ac019888ce 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5eb0df-cd2d-691c-e053-2995a90a2511 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL First Aid Research Corp. 7d1c0382-31b3-48d0-a514-c5cc45a2299e 2024-12-18 Warnings Exact identifier application number: M003 First Aid Only First Aid-Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Acme United Corporation f31a44ff-e4ac-de1e-e053-2a95a90ab036 2024-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer (Lavender Rosemary) HAND SANITIZER SPRAY Tubby Todd 2992a52a-21a9-18be-e063-6294a90a834d 2024-12-18 Warnings Exact identifier application number: M003 CVS Decolorized Iodine ALCOHOL CVS Pharmacy d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd 2024-12-18 Warnings Exact identifier application number: M003 De La Cruz Decolorized Iodine ETHYL ALCOHOL DLC Laboratories, Inc. 5d8f6aaa-0b87-1166-e053-2991aa0a297f 2024-12-18 Warnings Exact identifier application number: M003 Humco Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 1e078022-f32c-48bd-8add-f83aebcc5812 2024-12-18 Warnings Exact identifier application number: M003 Univ of Vermont Medical Center Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7841cfa9-e94e-4c3d-b5fb-676924017845 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital Mothers Vaginal ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7f1a85fd-086b-4fc7-abac-863dd3ea505a 2024-12-17 Warnings Exact identifier application number: M003
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0363-9654-10 00363965410 1 TUBE in 1 CARTON (0363-9654-10) / 75 mL in 1 TUBE 1 tube 2025-03-01 No No Current