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 93 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mary Kay Satin Hands Shea Hand Sanitizer ALCOHOL Mary Kay Inc. b6c2b979-2940-1569-e053-2995a90a532c 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive Decolorized Iodine ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981529a-2bd0-3e9e-e063-6294a90a7236 2024-12-17 Warnings Exact identifier application number: M003 Foster and Thrive 2% Mild Iodine Tincture IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID Strategic Sourcing Services, LLC 2981cb97-17de-ebda-e063-6394a90ad281 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital H.E.A.R.T. Strings Tote ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global, LLc f8369a27-1995-4fdd-a282-35c344c11d83 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital Amenity Kit ALCOHOL AND SODIUM MONOFLUOROPHOSPATE ASP Global, LLc 877ce875-c5b0-4d9b-8f00-682914e3bc0e 2024-12-17 Warnings Exact identifier application number: M003 Wellstar Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc ced9dd96-7922-43d7-906f-32afaad733ec 2024-12-17 Warnings Exact identifier application number: M003 Northside Hospital C-Section Mothers ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 9df6d0e9-631c-4619-9d96-d2c5a32a590e 2024-12-17 Warnings Exact identifier application number: M003 Memorial Sloan Kettering Cancer Center Amenity Kit SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc cab0bef1-f486-4eac-a61b-6030467d8650 2024-12-17 Warnings Exact identifier application number: M003 Sarasota Memorial Amenity ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc f5dda019-fcfd-4e99-89cc-e79e76b402e7 2024-12-17 Warnings Exact identifier application number: M003 Englewood Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7c9ce1bf-6aa2-4073-ad09-2ddf845102a2 2024-12-17 Warnings Exact identifier application number: M003 Mentholatum Moisturizing Hand Sanitizer BENZALKONIUM CHLORIDE The Mentholatum Company 365c93bc-2299-4e69-ba3a-69414bfe78d7 2024-12-13 Warnings Exact identifier application number: M003 Curaplex Alcohol Prep Pad ISOPROPYL ALCOHOL Sarnova, Inc. da1a4baa-05eb-4a75-82bb-39c547daef64 2024-12-12 Warnings Exact identifier application number: M003 Foaming Hand Sanitizer ALCOHOL Empack Spraytech Inc. 8bb072f2-9cd4-499d-9d7f-7166451b8f20 2024-12-12 Warnings Exact identifier application number: M003 Extra Stength Hand Sanitizer Zytec Germ Buster ALCOHOL 80%W/W Empack Spraytech Inc. da854195-3a50-4fae-a5ea-183bf524c973 2024-12-12 Warnings Exact identifier application number: M003 Zytec Hand Sanitizer Wipes 80% w/w Alcohol ALCOHOL Empack Spraytech Inc. ab86fd0c-40cd-0bb6-e053-2a95a90a76e2 2024-12-12 Warnings Exact identifier application number: M003 Dermoplast Kids First Aid BENZETHONIUM CHLORIDE AND BENZOCAINE Advantice Health, LLC. 29a18018-5214-4080-ac40-e646319e95ce 2024-12-12 Warnings Exact identifier application number: M003 New Skin Bandage BENZETHONIUM CHLORIDE Advantice Health, LLC. 5846f414-8329-4034-b99f-92721bdb3d14 2024-12-12 Warnings Exact identifier application number: M003 CVS Hand Sanitizer ALCOHOL CVS b5faeb31-67c7-2000-e053-2995a90a1409 2024-12-10 Warnings Exact identifier application number: M003 NEXXGEN 70% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 8d1a5c98-8169-4f40-8601-a6f6bbbbebe7 2024-12-09 Warnings Exact identifier application number: M003 NEXXGEN 91% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 12b8c85a-da0c-47a1-9531-c9f2858c4f31 2024-12-09 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