FDA.reportPublic FDA data

MicroKlenz Antimicrobial

Product NDC
53329-073
11-digit product format
533290073
Labeler code
53329
Product ID
53329-073_27d68dc5-75a6-16b6-e063-6394a90a1e8b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
Substance
BENZETHONIUM CHLORIDE
Active strength
.1 mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
MicroKlenz Antimicrobial
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.1 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
115dda08-709c-490a-9693-419b51441960Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-073-08MicroKlenz Antimicrobial236 mL in 1 BOTTLE, SPRAYLIQUID2367

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-073-08ML - Milliliter53329-07356346f5d-e863-4246-8c32-0e38f6eaa42312015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzethonium ChlorideACTIVE INGREDIENTPH41D05744MICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, INC.]2
BenzethoniumACTIVE MOIETY1VU15B70BPMICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPMICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, INC.]2
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXMICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, INC.]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TMICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, INC.]2
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74MICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RMICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-073MICROKLENZ ANTIMICROBIAL (BENZETHONIUM CHLORIDE) LIQUID [MEDLINE INDUSTRIES, LP]7Current NDC, Legacy NDC, 1 package rows20241127_115dda08-709c-490a-9693-419b51441960.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 90 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
application number: M003
Betadine SolutionPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.41891599-420e-48d2-8e31-d28a2209e3832025-01-06WarningsExact identifier
application number: M003
Signature Care Alcohol Prep PadISOPROPYL ALCOHOLBetter Living Brands LLCadc87331-1aa1-3457-e053-2a95a90a7eb12025-01-03WarningsExact identifier
application number: M003
Alcohol Extra-ThickISOPROPYL ALCOHOLMeijer Distribution Inc0b02643d-ea14-4877-ae9c-f0749d1b2d102025-01-03WarningsExact identifier
application number: M003
Premier ValueISOPROPYL ALCOHOLPharmacy Value Alliance, LLCd2baa47e-9673-7f23-e053-2a95a90adcb72025-01-03WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy88f761c1-cb50-4edc-9a54-43444378eff72025-01-03WarningsExact identifier
application number: M003
Sterile AlcoholISOPROPYL ALCOHOLChain Drug Marketing Association Inc55922632-3768-4450-9389-ba7d7d91f2c92025-01-03WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCASAD Company, Inc1e314157-c64e-492a-89ad-2b28831d551d2025-01-03WarningsExact identifier
application number: M003
BetadinePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.00002127-02bc-4c66-b0c3-ca29d8224afc2025-01-02WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d02e4d6-8751-b5bc-e063-6394a90a9d972025-01-01WarningsExact identifier
application number: M003
COVISIDE HAND SANITIZERISOPROPYL ALCOHOLCREAGEN INCa9f07fcd-4d5c-362c-e053-2a95a90a2e792024-12-30WarningsExact identifier
application number: M003
KEEPAN ABENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.a30679d5-5507-499d-9d9f-498095fd32ac2024-12-30WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-073-0853329007308236 mL in 1 BOTTLE, SPRAY (53329-073-08) 236 ml2007-01-010000-00-00NoNoCurrent