FDA.reportPublic FDA data

Keystone

Product NDC
47593-594
11-digit product format
475930594
Labeler code
47593
Product ID
47593-594_912823fb-4be3-43a4-a634-0d06c6ec86b8
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
2018-09-06
Substance
BENZALKONIUM CHLORIDE
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.14ba88a3-af32-4191-afed-cdcc7eb8ad6a2024-08-05WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use in eyes When using the product if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1731737

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
47593-594-11Keystone3780 mL in 1 BOTTLE, PLASTICSOLUTION37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-594KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]2Current NDC, Legacy NDC, 1 package rows20240806_14ba88a3-af32-4191-afed-cdcc7eb8ad6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapPSN14ba88a3-af32-4191-afed-cdcc7eb8ad6a2
1731737benzalkonium chloride 5 MG/ML Medicated Liquid SoapSCD14ba88a3-af32-4191-afed-cdcc7eb8ad6a2
1731737benzalkonium chloride 0.5 % Medicated Liquid SoapSY14ba88a3-af32-4191-afed-cdcc7eb8ad6a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-594-11475930594113780 mL in 1 BOTTLE, PLASTIC (47593-594-11) 3780 ml2018-09-060000-00-00NoNoCurrent