FDA.reportPublic FDA data

Ecolab

Product NDC
47593-593
11-digit product format
475930593
Labeler code
47593
Product ID
47593-593_9152f995-595f-4a30-8048-bf80bcf3b42c
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
2018-05-16
Substance
BENZALKONIUM CHLORIDE
Active strength
5.5 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
Ecolab
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE5.5 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
1549867Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
02d45eff-398a-44fe-bd56-5257cf596e7dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-593-41Ecolab750 mL in 1 BOTTLE, PLASTICSOLUTION7503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-593ECOLAB (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]3Current NDC, Legacy NDC, 1 package rows20240806_02d45eff-398a-44fe-bd56-5257cf596e7d.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
EcolabBENZALKONIUM CHLORIDEEcolab Inc.02d45eff-398a-44fe-bd56-5257cf596e7d2024-08-05WarningsExact identifier
ndc (product): 47593-593

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549867benzalkonium chloride 0.55 % Medicated Liquid SoapPSN02d45eff-398a-44fe-bd56-5257cf596e7d3
1549867benzalkonium chloride 5.5 MG/ML Medicated Liquid SoapSCD02d45eff-398a-44fe-bd56-5257cf596e7d3
1549867benzalkonium chloride 0.55 % Medicated Liquid SoapSY02d45eff-398a-44fe-bd56-5257cf596e7d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-593-4147593059341750 mL in 1 BOTTLE, PLASTIC (47593-593-41) 750 ml2018-05-160000-00-00NoNoCurrent