FDA.reportPublic FDA data

Antibacterial Lidocaine Wound Gel

Product NDC
0363-1652
11-digit product format
003631652
Labeler code
0363
Product ID
0363-1652_411fb13c-106b-be61-e063-6294a90a406e
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride, lidocaine hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
WALGREENS
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-05
Substance
LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength
2; .13 g/100mL; g/100mL
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
Antibacterial Lidocaine Wound Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2 g/100mL
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1431682Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eff77965-dc7f-49af-e053-2995a90a1a97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1652-28Antibacterial Lidocaine Wound Gel28 mL in 1 TUBEGEL283
0363-1652-28Antibacterial Lidocaine Wound Gel1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1652ANTIBACTERIAL LIDOCAINE WOUND GEL (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [WALGREENS]2Current NDC, Legacy NDC, 2 package rows20241107_eff77965-dc7f-49af-e053-2995a90a1a97.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 87 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stopain Extra StrengthMENTHOLTroy Manufacturing, Inc.07e9a235-6d10-4407-8729-beaf936e97ad2025-07-03WarningsExact identifier
application number: M017
Blue Ice Topical Analgesic GelICE GELInternational Wholesale397cd306-078d-5b7d-e063-6294a90a8bbc2025-07-03WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINE, MENTHOLVive Health LLC236ccc6d-21b7-6153-e063-6394a90a46342025-07-02WarningsExact identifier
application number: M017
AsperFlex MAXLIDOCAINE 4% WITH MENTHOL 1%Akron Pharma Inc.ccf6172b-350a-4b78-b844-f84bf17c491f2025-07-02WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3766e3a9-94a8-4c3e-e063-6394a90aa24a2025-07-01WarningsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESun Pharmaceutical Industries, Inc.c89e3de8-7d71-485c-8fc5-2832d6024f162025-07-01WarningsExact identifier
application number: M017
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
application number: M017
Cortizone 10 Water ResistantHYDROCORTISONEChattem, Inc.118e55e7-241f-44c4-959e-09bf6221bd772025-07-01WarningsExact identifier
application number: M017
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
application number: M017
Plantar Fasciitis CreamCAMPHORSOLALIA LLC388f33c2-2bdf-ded8-e063-6294a90aeeac2025-06-27WarningsExact identifier
application number: M017
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateANTI-ITCH CONTINUOUS SPRAYWal-Mart Stores, Inc.709c3bb8-5b36-4823-941a-45ddb3e431c42025-06-27WarningsExact identifier
application number: M017
Burn Relief Professional Bio-KoolLIDOCAINE - 4%Kool-Down Inc.827e9c69-4706-0ccf-e053-2991aa0aa1c12025-06-27WarningsExact identifier
application number: M017
Lidocaine PatchLIDOCAINEShenzhen Finona Information Technology Co., Ltd3875bde5-2e1a-5fdf-e063-6294a90a3c0d2025-06-26WarningsExact identifier
application number: M017
SupreH Bee Venom Arthritis Pain Relieving CreamSUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3876cc44-7f3a-b084-e063-6294a90a61422025-06-26WarningsExact identifier
application number: M017
MediBalmHYDROCORTISONEBalmRx, LLC324dd151-84c5-3e2f-e063-6394a90a569d2025-06-26WarningsExact identifier
application number: M017
PHIZICO Pain ReliefMENTHOLER3 BRANDS INC.72715dc5-d1e7-4b4b-8e28-4e367abba3222025-06-25WarningsExact identifier
application number: M017
Diva Cramp Care CreamMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp37368566-b14e-4d5c-bdde-6eea9073974f2025-06-25WarningsExact identifier
application number: M017
H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTHLIDOCAINE HCLH2Ocean, LLC386bf11b-1d71-44bf-e063-6394a90a28172025-06-25WarningsExact identifier
application number: M017
Burn Relief Extra Strength Kool-DownLIDOCAINE - 3.9%Kool-Down Inc827fec2f-db3c-adbb-e053-2a91aa0a7c172025-06-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431682benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical GelPSNeff77965-dc7f-49af-e053-2995a90a1a973
1431682benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical GelSCDeff77965-dc7f-49af-e053-2995a90a1a973
1431682benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical GelSYeff77965-dc7f-49af-e053-2995a90a1a973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1652-28003631652281 TUBE in 1 CARTON (0363-1652-28) / 28 mL in 1 TUBE1 tube2022-12-050000-00-00NoNoCurrent