FDA.reportPublic FDA data

EcoCare 280

Product NDC
47593-646
Requested package NDC
47593-646-11
11-digit product format
475930646
Labeler code
47593
Product ID
47593-646_80bd8826-2119-4333-9745-f90610a3981b
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
2022-02-07
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
EcoCare 280
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
2377530Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89e45f4c-7599-4070-9f7c-07c7286e3c6fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-646-11EcoCare 2803780 mL in 1 BOTTLESOLUTION37802
47593-646-21EcoCare 280208000 mL in 1 DRUMSOLUTION2080002
47593-646-59EcoCare 2801250 mL in 1 BOTTLESOLUTION12502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-646ECOCARE 280 (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]2Current NDC, Legacy NDC, 3 package rows20240807_89e45f4c-7599-4070-9f7c-07c7286e3c6f.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
EcoCare 280BENZALKONIUM CHLORIDEEcolab Inc.89e45f4c-7599-4070-9f7c-07c7286e3c6f2024-08-06WarningsExact identifier
ndc (package): 47593-646-11
ndc (product): 47593-646
ndc11 (package): 47593064611

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2377530benzalkonium chloride 0.5 % Topical SolutionPSN89e45f4c-7599-4070-9f7c-07c7286e3c6f2
2377530benzalkonium chloride 5 MG/ML Topical SolutionSCD89e45f4c-7599-4070-9f7c-07c7286e3c6f2
2377530benzalkonium chloride 0.5 % Topical SolutionSY89e45f4c-7599-4070-9f7c-07c7286e3c6f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-646-11475930646113780 mL in 1 BOTTLE (47593-646-11) 3780 ml2022-02-070000-00-00NoNoCurrent