FDA.reportPublic FDA data

A-Cute Derm B-Kleer

Product NDC
68605-1040
11-digit product format
686051040
Labeler code
68605
Product ID
68605-1040_3abba027-97ff-4ae6-8fa8-66e544bf9fd0
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
GEL
Route
CUTANEOUS
Labeler
ABBE Laboratories, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
BENZETHONIUM CHLORIDE
Active strength
2 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
A-Cute Derm B-Kleer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1243889Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
544333fe-6c3a-485b-b899-e029d97ea962Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68605-1040-2A-Cute Derm B-Kleer946.35 mL in 1 BOTTLE, PLASTICGEL946.353
68605-1040-4A-Cute Derm B-Kleer118.29 mL in 1 BOTTLE, PLASTICGEL118.293
68605-1040-8A-Cute Derm B-Kleer236.59 mL in 1 BOTTLE, PLASTICGEL236.593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68605-1040A-CUTE DERM B-KLEER (BENZETHONIUM CHLORIDE) GEL [ABBE LABORATORIES, INC.]2Current NDC, Legacy NDC, 3 package rows20240202_544333fe-6c3a-485b-b899-e029d97ea962.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 14 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacitracin ZincBACITRACIN ZINCRugby Laboratoriesac3c9897-c812-1360-e053-2a95a90ad5912024-12-17WarningsExact identifier
application number: M004
Major BacitracinBACITRACIN ZINCMajor Pharmaceuticalsa23ce772-7078-0a4b-e053-2995a90aff0d2024-12-17WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCeea0d90c-914b-2624-e053-2a95a90a34c92024-12-13WarningsExact identifier
application number: M004
OP First Aid Series TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.cadebf07-dd48-4855-8296-7a91e28d71232024-12-05WarningsExact identifier
application number: M004
triple antibiotic and pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyf0864d78-23e6-4e6c-bc67-7ba3e6dd862c2024-12-03WarningsExact identifier
application number: M004
triple antibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEPublix Super Markets Inc330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f92024-11-25WarningsExact identifier
application number: M004
WinCo Maximum Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDEWinCo Foods, LLC01b03c7e-6c4e-43aa-8480-aff1c2688f7f2024-11-21WarningsExact identifier
application number: M004
WinCo Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWinCo Foods, LLCe364b623-6e20-4894-8d4c-5c739be78f862024-11-21WarningsExact identifier
application number: M004
Winco Bacitracin ZincBACITRACIN ZINCWinCo Foods, LLCdcdf647f-fa32-4b72-b714-a77e8e3323582024-11-21WarningsExact identifier
application number: M004
Walgreens Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyf4feccc3-ac25-4d8a-9b68-9a24f755524a2024-11-20WarningsExact identifier
application number: M004
Walgreens Kids Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyfbc364d7-d8b8-43f5-99cc-290438f3982b2024-11-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf9a48f73-aa12-cf68-e053-6294a90a8e532024-11-19WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEAcme United Corporatione55cbf7e-c955-7f1a-e053-2a95a90a3f282024-11-19WarningsExact identifier
application number: M004
First Aid Only Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf4eba34c-ce31-3004-e053-2995a90a245b2024-11-19WarningsExact identifier
application number: M004
First Aid Only Neomycin AntibioticNEOMYCIN SULFATEAcme United Corporationc651e98e-aabe-de46-e053-2a95a90a63072024-11-19WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCf07d3bca-4312-46ed-b0c4-f886c01bd0952024-11-14WarningsExact identifier
application number: M004
Polysporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLCe0fcf83e-a374-4fc0-a629-8730330543922024-11-14WarningsExact identifier
application number: M004
Neosporin Pain Itch ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC55392c48-b5d8-44cd-8c10-6d86683498482024-11-13WarningsExact identifier
application number: M004
Neosporin Kids Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC6752f0a0-2432-4d8b-8198-74ae96a689632024-11-13WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCa3e6fe2e-1b74-4f22-9c7c-a000574396902024-11-13WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243889benzethonium chloride 0.2 % Medicated Liquid SoapPSN544333fe-6c3a-485b-b899-e029d97ea9623
1243889benzethonium chloride 2 MG/ML Medicated Liquid SoapSCD544333fe-6c3a-485b-b899-e029d97ea9623
1243889benzethonium chloride 0.2 % Medicated Liquid SoapSY544333fe-6c3a-485b-b899-e029d97ea9623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68605-1040-268605104002946.35 mL in 1 BOTTLE, PLASTIC (68605-1040-2) 946.35 ml2022-05-010000-00-00NoNoCurrent
68605-1040-468605104004118.29 mL in 1 BOTTLE, PLASTIC (68605-1040-4) 118.29 ml2022-05-010000-00-00NoNoCurrent
68605-1040-868605104008236.59 mL in 1 BOTTLE, PLASTIC (68605-1040-8) 236.59 ml2022-05-010000-00-00NoNoCurrent
68605-1040-9686051040091 BOTTLE, PLASTIC in 1 BOX (68605-1040-9) > 29.57 mL in 1 BOTTLE, PLASTIC (68605-1040-1) 2022-05-010000-00-00NoNoCurrent