FDA.reportPublic FDA data

Advanced Antibacterial Clean and Smooth

Product NDC
47593-575
11-digit product format
475930575
Labeler code
47593
Product ID
47593-575_a9f4497a-97d1-4b3b-a4d6-bb1ac46abf70
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Ecolab Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-25
Substance
BENZALKONIUM CHLORIDE
Active strength
5 mg/mL
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
Advanced Antibacterial Clean and Smooth
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1731737Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
881a94a1-68b8-4152-bdaa-e736812e889aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-575-11Advanced Antibacterial Clean and Smooth3780 mL in 1 BOTTLESOLUTION37806
47593-575-41Advanced Antibacterial Clean and Smooth750 mL in 1 BOTTLESOLUTION7506
47593-575-59Advanced Antibacterial Clean and Smooth1250 mL in 1 BOTTLESOLUTION12506
47593-575-70Advanced Antibacterial Clean and Smooth1200 mL in 1 BOTTLESOLUTION12006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-575ADVANCED ANTIBACTERIAL CLEAN AND SMOOTH (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6Current NDC, Legacy NDC, 4 package rows20241211_881a94a1-68b8-4152-bdaa-e736812e889a.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Antibacterial Clean and SmoothBENZALKONIUM CHLORIDEEcolab Inc.881a94a1-68b8-4152-bdaa-e736812e889a2024-12-10WarningsExact identifier
ndc (product): 47593-575

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSN881a94a1-68b8-4152-bdaa-e736812e889a6
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCD881a94a1-68b8-4152-bdaa-e736812e889a6
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSY881a94a1-68b8-4152-bdaa-e736812e889a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-575-11475930575113780 mL in 1 BOTTLE (47593-575-11) 3780 ml2017-05-250000-00-00NoNoCurrent
47593-575-4147593057541750 mL in 1 BOTTLE (47593-575-41) 750 ml2017-05-250000-00-00NoNoCurrent
47593-575-59475930575591250 mL in 1 BOTTLE (47593-575-59) 1250 ml2017-05-250000-00-00NoNoCurrent
47593-575-70475930575701200 mL in 1 BOTTLE (47593-575-70) 1200 ml2024-12-10NoNoCurrent