FDA.reportPublic FDA data

Ecolab

Product NDC
47593-613
11-digit product format
475930613
Labeler code
47593
Product ID
47593-613_7f24bc59-3066-4f1e-a8a5-5a59964f203e
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
2019-06-19
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
Ecolab
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
acdce645-5a74-4a45-aa7b-6f08bc8c89afAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-613-41Ecolab750 mL in 1 BOTTLE, PLASTICSOLUTION7504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-613ECOLAB (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]4Current NDC, Legacy NDC, 1 package rows20240806_acdce645-5a74-4a45-aa7b-6f08bc8c89af.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.acdce645-5a74-4a45-aa7b-6f08bc8c89af2024-08-05WarningsExact identifier
ndc (product): 47593-613

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSNacdce645-5a74-4a45-aa7b-6f08bc8c89af4
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCDacdce645-5a74-4a45-aa7b-6f08bc8c89af4
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSYacdce645-5a74-4a45-aa7b-6f08bc8c89af4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-613-4147593061341750 mL in 1 BOTTLE, PLASTIC (47593-613-41) 750 ml2019-06-190000-00-00NoNoCurrent