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 55 of 114 · 2,277 matching rows.
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