FDA.reportPublic FDA data

A-Cute Derm Antisepation

Product NDC
68605-7171
11-digit product format
686057171
Labeler code
68605
Product ID
68605-7171_3a172d4c-117c-4e15-b710-7d78a9146b69
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 Antisepation
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d7e69169-dc8a-4ad7-b8bb-d97a5d30cbecAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68605-7171-2A-Cute Derm Antisepation946.4 mL in 1 BOTTLE, PLASTICGEL946.43
68605-7171-4A-Cute Derm Antisepation118.294 mL in 1 BOTTLE, PLASTICGEL118.2943
68605-7171-8A-Cute Derm Antisepation236.6 mL in 1 BOTTLE, PLASTICGEL236.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68605-7171A-CUTE DERM ANTISEPATION (BENZETHONIUM CHLORIDE) GEL [ABBE LABORATORIES, INC.]2Current NDC, Legacy NDC, 3 package rows20240209_d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec.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 1 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
application number: M004
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
application number: M004
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTICNantong Health & Beyond Hygienic Products Inc.5a7cb52d-a60c-b947-e063-6394a90afb0d2026-09-02WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BWalgreen Company4f3cfe39-2df8-48b4-954d-5997217c92ba2026-08-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsExact identifier
application number: M004
OP Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEYiwu Ori-Power Medtech Co., Ltd.03f3cce9-7e9f-90a6-e063-6294a90a660b2026-08-28WarningsExact identifier
application number: M004
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
application number: M004
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
application number: M004
Be Smart Get Prepared Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETotal Resources International, Inc57ed1a03-7e1b-4eb4-8001-dfd118805edc2026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINCGentell LLC59c5a363-6d79-d07e-e063-6294a90a87532026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN BGentell LLC597cb2f0-ff05-a1ab-e063-6294a90acda92026-08-20WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEShield Line LLC5ba3e703-7873-4724-a0bf-bb22d8a257482026-08-18WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINCShield Line LLCe6a6fb0f-5ab7-4647-84a0-7b9948eed3032026-08-18WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68605-7171-268605717102946.4 mL in 1 BOTTLE, PLASTIC (68605-7171-2) 946.4 ml2022-05-010000-00-00NoNoCurrent
68605-7171-468605717104118.294 mL in 1 BOTTLE, PLASTIC (68605-7171-4) 118.294 ml2022-05-010000-00-00NoNoCurrent
68605-7171-868605717108236.6 mL in 1 BOTTLE, PLASTIC (68605-7171-8) 236.6 ml2022-05-010000-00-00NoNoCurrent