FDA.reportPublic FDA data

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
IngredientStrength
BENZALKONIUM CHLORIDE13 mg/mL
LIDOCAINE HYDROCHLORIDE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25a1e89b-bafd-4770-e063-6294a90a14d2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9654-10Walgreens Max Strength Burn Gel1 in 1 CARTONGEL14
0363-9654-10Walgreens Max Strength Burn Gel75 mL in 1 TUBEGEL754

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 56 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d300-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)MY IMPORTS USA LLC421f3150-2027-c6aa-e063-6294a90ab6aa2025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.421b402e-233d-cebf-e063-6394a90aa4212025-10-27WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.637dcb5f-8870-4613-a227-9fd6126170612025-10-27WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER SET WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42143916-8d2e-dbbe-e063-6294a90a29c42025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER SET CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42147184-18e6-f932-e063-6294a90a807e2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214ba08-8d00-8de9-e063-6394a90a4c902025-10-26WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214f0de-6b1d-dae7-e063-6294a90ade422025-10-26WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4215130c-a298-02c7-e063-6394a90a74ff2025-10-26WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd421b1732-acdd-a6cc-e063-6394a90a5fb42025-10-26WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Soft BerryETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce569-f2d3-c1e0-e063-6294a90a822f2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1f66d-45f6-bb9a-e063-6394a90a06aa2025-10-26WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLCardinal Healthc95bfab6-bab4-79f3-e053-2995a90a80912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6e97d7-7eea-f7ca-e063-6394a90a4ecd2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC3a6cabf7-9310-cba5-e063-6394a90a3f912025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC39529f87-ed4e-52b8-e063-6394a90af8792025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLPhoenix Healthcare Solutions LLCf0b55f6c-4afd-2154-e053-2995a90afcfa2025-10-23WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9654-10003639654101 TUBE in 1 CARTON (0363-9654-10) / 75 mL in 1 TUBE1 tube2025-03-01NoNoCurrent