FDA.reportPublic FDA data

Antibacterial

Product NDC
68599-5501
Requested package NDC
68599-5501-2
11-digit product format
685995501
Labeler code
68599
Product ID
68599-5501_24381ab3-73da-f89a-e063-6394a90ab30a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
McKesson
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-29
Substance
BENZETHONIUM CHLORIDE
Active strength
.13 g/100mL
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
Antibacterial
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.13 g/100mL

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
1039026Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58892abf-e0b9-83d9-e053-2a91aa0ad035Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68599-5501-12020-03-28McKesson Antibacterial Soap
68599-5501-22020-03-28McKesson Antibacterial Soap
68599-5501-32020-03-28McKesson Antibacterial Soap
68599-5501-42020-03-28McKesson Antibacterial Soap
68599-5501-12020-01-31McKesson Antibacterial Soap
68599-5501-22020-01-31McKesson Antibacterial Soap
68599-5501-32020-01-31McKesson Antibacterial Soap
68599-5501-42020-01-31McKesson Antibacterial Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5501-1Antibacterial3785 mL in 1 BOTTLELIQUID37854
68599-5501-2Antibacterial1000 mL in 1 BOTTLELIQUID10004
68599-5501-3Antibacterial237 mL in 1 BOTTLE, DISPENSINGLIQUID2374
68599-5501-4Antibacterial532 mL in 1 BOTTLE, DISPENSINGLIQUID5324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5501ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [MCKESSON]4Current NDC, Legacy NDC, 4 package rows20241013_58892abf-e0b9-83d9-e053-2a91aa0ad035.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 61 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Lift Antibacterial Body WashBENZALKONIUM CHLORIDESpa de Soleilab9dde33-1bd2-062f-e053-2a95a90a4d182025-10-10WarningsExact identifier
application number: M003
Dr Lift AntibacterialBENZALKONIUM CHLORIDESpa de Soleilaf89675e-e66f-0922-e053-2995a90ab9d22025-10-10WarningsExact identifier
application number: M003
ANTISEPTIC WIPE 01BENZALKONIUM CHLORIDETotal Resources International Inc.cf4a6a97-529e-7f11-e053-2a95a90a75a92025-10-10WarningsExact identifier
application number: M003
Be Smart Get Prepared Sting Relief WipeALCOHOL, LIDOCAINE HYDROCHLORIDETotal Resources International, Incfff6f057-739e-40f1-8427-e1364c65af052025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLZhejiang Hudson Import& Export Co., Ltd40b6c96c-e36f-6588-e063-6394a90adb462025-10-09WarningsExact identifier
application number: M003
CuradISOPROPYL ALCOHOLMedline Industries, LPc42de981-4e3f-1ac9-e053-2995a90aea982025-10-09WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLAvaria Health & Beauty Corpa3d87ef6-752b-b54b-e053-2a95a90af9632025-10-08WarningsExact identifier
application number: M003
MediChoice BZK AntisepticBENZALKONIUM CHLORIDEO&M HALYARD, INC.82a7710d-a9fa-4f68-8322-046a765ae9292025-10-08WarningsExact identifier
application number: M003
MediChoice CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.79d41cf0-301f-44d4-a76c-f4850c7ddce92025-10-08WarningsExact identifier
application number: M003
MediChoice Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLO&M HALYARD, INC.8b84c8ed-040e-4c07-94cb-d5bdda7446482025-10-08WarningsExact identifier
application number: M003
MediChoice of Hydrogen Peroxide 3 10 VolumeHYDROGEN PEROXIDEO&M HALYARD, INC.34e77ef4-297d-4362-8f6e-abf80158b7f02025-10-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEO&M HALYARD, INC.0ad5990a-a18d-4753-826b-6da3139266982025-10-08WarningsExact identifier
application number: M003
equate SwabsticksISOPROPYL ALCOHOLWalmart Inc.cd4a4490-bb02-436d-853b-f73261d358c62025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEFoodhold USA1e897ee5-17e3-459e-88e3-d7436ee22f372025-10-07WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEPremier Brands of America Inc.051b68f9-5d6c-3cd7-e063-6394a90aeb352025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEHEB40b71196-a2ac-4a44-8046-c448d066baa22025-10-07WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEAmerisourceBergen Drug Corporation5c82c4db-258e-4647-aec9-1c4520e0468a2025-10-07WarningsExact identifier
application number: M003
Premier Solutions Liquid BandageBENZETHONIUM CHLORIDE DYCLONINE HYDROCHLORIDEPremier Brands of America, Inc.e196d4c2-a93e-a03c-e053-2995a90a3ea32025-10-07WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEWinCo Foods LLC15d855fe-491e-4982-e063-6394a90aea1d2025-10-07WarningsExact identifier
application number: M003
LOCKE TEDDYALCOHOL ANTISEPTICKINGKEY MBC LIFE TECHNOLOGY GROUP CO.,LTD7c0056c1-3add-49f6-8816-b61a7f5a05082025-10-07WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039026benzethonium chloride 0.13 % Medicated Liquid SoapPSN58892abf-e0b9-83d9-e053-2a91aa0ad0354
1039026benzethonium chloride 1.3 MG/ML Medicated Liquid SoapSCD58892abf-e0b9-83d9-e053-2a91aa0ad0354
1039026benzethonium chloride 0.13 % Medicated Liquid SoapSY58892abf-e0b9-83d9-e053-2a91aa0ad0354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-5501-2685995501021000 mL in 1 BOTTLE (68599-5501-2) 1000 ml2017-09-290000-00-00NoNoCurrent