FDA.reportPublic FDA data

Ecolab

Product NDC
47593-581
11-digit product format
475930581
Labeler code
47593
Product ID
47593-581_fec64806-f550-4ff4-9164-ea15b3eb4fde
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
2017-05-18
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ecolab
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 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
1038791Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b0701df-130b-49c4-8df6-101202e655abAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-581-41Ecolab750 mL in 1 BOTTLE, PLASTICSOLUTION7504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-581ECOLAB (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]3Current NDC, Legacy NDC, 1 package rows20240805_5b0701df-130b-49c4-8df6-101202e655ab.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.5b0701df-130b-49c4-8df6-101202e655ab2025-12-30WarningsExact identifier
ndc (product): 47593-581

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038791benzalkonium chloride 0.1 % Topical SolutionPSN5b0701df-130b-49c4-8df6-101202e655ab4
1038791benzalkonium chloride 1 MG/ML Topical SolutionSCD5b0701df-130b-49c4-8df6-101202e655ab4
1038791benzalkonium chloride 0.1 % Topical SolutionSY5b0701df-130b-49c4-8df6-101202e655ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-581-4147593058141750 mL in 1 BOTTLE, PLASTIC (47593-581-41) 750 ml2017-05-180000-00-00NoNoCurrent