Keystone

Product NDC
47593-359
11-digit product format
475930359
Labeler code
47593
Product ID
47593-359_e29e91d1-65ac-46ba-a572-465697b0f6ab
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
2002-07-26
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 mg/100mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038799Internal RxNorm lookup
1038855Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b742f102-a60c-4ed0-8d6c-d6721c9ec5dcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47593-359-41Keystone750 mL in 1 BOTTLE, PLASTICSOLUTION75010
47593-359-56Keystone1200 mL in 1 BOTTLE, PLASTICSOLUTION120010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YKEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RKEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47593-359KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]10Current NDC, Legacy NDC, 2 package rows20240321_b742f102-a60c-4ed0-8d6c-d6721c9ec5dc.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
KeystoneBENZALKONIUM CHLORIDEEcolab Inc.b742f102-a60c-4ed0-8d6c-d6721c9ec5dc2024-03-19WarningsExact identifier
ndc (product): 47593-359

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSNb742f102-a60c-4ed0-8d6c-d6721c9ec5dc10
1038855KEYSTONE Classic 0.1 % Topical FoamPSNb742f102-a60c-4ed0-8d6c-d6721c9ec5dc10
1038855benzalkonium chloride 1 MG/ML Topical Foam [Keystone]SBDb742f102-a60c-4ed0-8d6c-d6721c9ec5dc10
1038799benzalkonium chloride 1 MG/ML Topical FoamSCDb742f102-a60c-4ed0-8d6c-d6721c9ec5dc10
1038799benzalkonium chloride 0.1 % Topical FoamSYb742f102-a60c-4ed0-8d6c-d6721c9ec5dc10
1038855Keystone 1 MG/ML Topical FoamSYb742f102-a60c-4ed0-8d6c-d6721c9ec5dc10
1038855Keystone Classic 0.1 % Topical FoamSYb742f102-a60c-4ed0-8d6c-d6721c9ec5dc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47593-359-4147593035941750 mL in 1 BOTTLE, PLASTIC (47593-359-41) 750 ml2002-07-260000-00-00NoNoCurrent
47593-359-56475930359561200 mL in 1 BOTTLE, PLASTIC (47593-359-56) 1200 ml2002-07-260000-00-00NoNoCurrent