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 5 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ora Zen Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incabbf8c34-87cb-4366-9840-7264a5114b542026-03-11WarningsExact identifier
application number: M004
FM-24 FOAMINGCHLOROXYLENOLPeople's Janitorial Supplyb3c2e174-6099-ba08-e053-2995a90a72902026-03-10WarningsExact identifier
application number: M004
doubleantibioticointmentBACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC4eb5202e-8e5b-6d31-e054-00144ff88e882026-03-04WarningsExact identifier
application number: M004
Neomycin SulfateNEOMYCIN SULFATEAldermed Inc.4978bb06-8b7c-9a44-e063-6294a90ac4cf2026-02-12WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTIC FIRST AID ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENatureplex LLCfbb64891-2219-451d-96b0-e7c0430fadda2026-02-12WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATUS PHARMACEUTICALS INCf64b3564-ea3c-4316-8f00-f92c08dcad352026-02-04WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, AND PRAMIXINE HCLVeridian Healthcared2374664-4668-4da5-9df7-44e6e421ad542026-01-29WarningsExact identifier
application number: M004
TheraCare Bacitracin ZincFIRST AID ANTIBIOTICVeridian Healthcare8217648d-5acb-4a1e-913f-43695f4e01ad2026-01-29WarningsExact identifier
application number: M004
Equate First Aid Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart907d44c5-cbd1-4d13-8c5c-c164f7a536e52026-01-29WarningsExact identifier
application number: M004
Natureplex Antibiotic plus PainBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex, LLC317acec2-8ab7-4b62-9d72-f98cab4f979c2026-01-29WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4963f926-3d48-36de-e063-6294a90a9acc2026-01-27WarningsExact identifier
application number: M004
A-Cute Derm AntisepationBENZETHONIUM CHLORIDEABBE Laboratories, Inc.d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec2026-01-24WarningsExact identifier
application number: M004
A-Cute Derm B-KleerBENZETHONIUM CHLORIDEABBE Laboratories, Inc.544333fe-6c3a-485b-b899-e029d97ea9622026-01-24WarningsExact identifier
application number: M004
ndc (product): 68605-1040
Brace ReliefBENZOCAINEInfaLab,Incd7e57d67-4234-44a9-bbd3-72e99cd5bdb32026-01-16WarningsExact identifier
application number: M004
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLC0e1f57c4-8b46-b8cc-e063-6294a90a0ebb2026-01-15WarningsExact identifier
application number: M004
ViaDerma Care Tetracycline HCl First Aid AntibioticTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.5437777e-7f2b-412d-a2f5-380c09de4b1d2026-01-14WarningsExact identifier
application number: M004
Hermon bed sore and pressure sore creamCALENDULA OFFICINALIS1X HPUS 1.5%Beautivity LLC48053402-b6c8-0443-e063-6294a90abce72026-01-10WarningsExact identifier
application number: M004
Walgreens Arthritis Pain Relief Capsaicin AnalgesicCAPSAICINWalgreen Companyda818dd5-bf64-46c2-a3ad-440b2874edbb2026-01-09WarningsExact identifier
application number: M004
QS Plus Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEABC Compounding Co., Inc.343f9139-47bc-44b0-9da1-d9d6f6334bc72026-01-06WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B SULFATEMelaleuca, Inc.65ae4607-689d-6056-e053-2a91aa0aff562025-12-31WarningsExact 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