Home NDC 42961-615 Antibacterial Foaming Hand
Product NDC 42961-615
11-digit product format 429610615
Labeler code 42961
Product ID 42961-615_f4424fa9-e860-4ef1-b55c-9b162f782ffc
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SOAP
Route TOPICAL
Labeler Cintas
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-01
Substance BENZALKONIUM CHLORIDE
Active strength 13 mg/10mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Antibacterial Foaming Hand
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 13 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046593 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42961-615-01 Antibacterial Foaming Hand 10 in 1 CARTON SOAP 10 9 42961-615-01 Antibacterial Foaming Hand 500 mL in 1 BAG SOAP 500 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42961-615 ANTIBACTERIAL FOAMING HAND (BENZALKONIUM CHLORIDE) SOAP [CINTAS] 8 Current NDC, 2 package rows 20240711_765ae77c-e48b-4996-82d1-cec8ed7c846f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42961-615-01 42961061501 10 BAG in 1 CARTON (42961-615-01) / 500 mL in 1 BAG 10 bag 2022-06-01 No No Current