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 17 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DG Health AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC0a04da51-d169-4eff-b70c-352913ce39662024-10-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway8d5bac6b-98b6-4fc4-983a-ca5292b4c3612024-10-06WarningsExact identifier
application number: M004
antibiotic plus pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEKroger Company91828614-d0d1-472f-802f-43f4738601252024-09-26WarningsExact identifier
application number: M004
DG Health AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp Incefaf3ea5-0a2f-414f-96eb-7e8cfba9e9012024-09-26WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutions29c223ff-3cb7-4578-a326-08516e89cd472024-09-26WarningsExact identifier
application number: M004
Signature Care First Aid AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway78ecfb28-f4c4-4f70-90c9-d6d7bf920fb52024-09-26WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmerisource Bergen3d1694ea-3f3e-45d5-8edf-8b31ac7d3a402024-09-26WarningsExact identifier
application number: M004
Rexall AntibioticBACITRACINDolgencorp, LLC7ad42602-6e42-47c8-91a8-e4785fa8d24b2024-09-23WarningsExact identifier
application number: M004
bacitracinBACITRACINH E B0a5eeef0-309b-4edd-a664-3d9c1c74a6e92024-09-23WarningsExact identifier
application number: M004
signature care first aid antibioticBACITRACINSafeway38fc0c5c-e0bc-44d2-acbd-d4d329fef1e12024-09-23WarningsExact identifier
application number: M004
AntibioticBACITRACINTopco Associates LLC3267a695-9e53-42f2-b30a-022653a0b8bb2024-09-23WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger Company4490cece-0635-4ea7-91ab-324a971fef632024-09-23WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPadagis Israel Pharmaceuticals Ltd28fff253-ddd4-4669-aa90-b4caf48c905f2024-09-22WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSafeway044aff98-f398-40f5-8c18-2751b4ab43842024-09-18WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAmerican Sales Company09a0b0b9-1806-4ff9-80fa-448dabbf2cc72024-09-18WarningsExact identifier
application number: M004
equaline first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BUnited Natural Foods, Inc. dba UNFI022e009e-0192-4089-86f3-4d63448e0f882024-09-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BKroger Companyc531bac4-ab15-4fde-99a7-19e20ce103872024-09-17WarningsExact identifier
application number: M004
basic care first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BAmazon.com Services LLCc159b18d-0d6e-409f-8b2b-e8f28cd856332024-09-17WarningsExact identifier
application number: M004
Major Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFATMajor Pharmaceuticalsa6cc3fbc-6302-4033-e053-2a95a90a19f02024-09-11WarningsExact identifier
application number: M004
Leader Triple antibioticBACITRACIN,NEOMYCIN,POLYMXINCardinal Health 110 dba LEADER2175e00a-bf85-3377-e063-6394a90a916f2024-09-06WarningsExact 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