FDA.reportPublic FDA data

Swisher

Product NDC
47593-591
Requested package NDC
47593-591-41
11-digit product format
475930591
Labeler code
47593
Product ID
47593-591_842818aa-22c4-4bc6-b1c7-9978020a6923
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
2018-06-20
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
Swisher
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
04e2f617-0643-4097-8780-b64c58c5b56cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-591-41Swisher750 mL in 1 BOTTLE, PLASTICSOLUTION7503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-591SWISHER (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]3Current NDC, Legacy NDC, 1 package rows20240806_04e2f617-0643-4097-8780-b64c58c5b56c.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
SwisherBENZALKONIUM CHLORIDEEcolab Inc.04e2f617-0643-4097-8780-b64c58c5b56c2024-08-05WarningsExact identifier
ndc (package): 47593-591-41
ndc (product): 47593-591
ndc11 (package): 47593059141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSN04e2f617-0643-4097-8780-b64c58c5b56c3
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCD04e2f617-0643-4097-8780-b64c58c5b56c3
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSY04e2f617-0643-4097-8780-b64c58c5b56c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-591-4147593059141750 mL in 1 BOTTLE, PLASTIC (47593-591-41) 750 ml2018-06-200000-00-00NoNoCurrent