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
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
.13; 2 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

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial Lidocaine Wound Gel
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui1431682

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

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