Foaming Advanced Antibacterial Hand

Product NDC
50865-213
Requested package NDC
50865-213-52
11-digit product format
508650213
Labeler code
50865
Product ID
50865-213_298e23fa-a68d-383f-e063-6294a90a2e34
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Kutol Products Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.003 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Foaming Advanced Antibacterial Hand
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.003 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7abc56b5-4446-4464-9b94-6c55f8bb9b74Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-213-13Foaming Advanced Antibacterial Hand3785 mL in 1 BOTTLE, PLASTICSOAP37859
50865-213-17Foaming Advanced Antibacterial Hand50 mL in 1 BOTTLE, PLASTICSOAP509
50865-213-24Foaming Advanced Antibacterial Hand1000 mL in 1 BOTTLE, PLASTICSOAP10009
50865-213-41Foaming Advanced Antibacterial Hand1000 mL in 1 BAGSOAP10009
50865-213-50Foaming Advanced Antibacterial Hand1200 mL in 1 BAGSOAP12009
50865-213-52Foaming Advanced Antibacterial Hand1000 mL in 1 BOTTLE, PLASTICSOAP10009
50865-213-78Foaming Advanced Antibacterial Hand950 mL in 1 BOTTLE, PLASTICSOAP9509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-213FOAMING ADVANCED ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY]9Current NDC, Legacy NDC, 7 package rows20241220_7abc56b5-4446-4464-9b94-6c55f8bb9b74.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
Foaming Advanced Antibacterial HandBENZALKONIUM CHLORIDEKutol Products Company7abc56b5-4446-4464-9b94-6c55f8bb9b742024-12-18WarningsExact identifier
ndc (package): 50865-213-52
ndc (product): 50865-213
ndc11 (package): 50865021352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50865-213-52508650213521000 mL in 1 BOTTLE, PLASTIC (50865-213-52) 1000 ml2015-10-010000-00-00NoNoCurrent