Home NDC 76162-897-03 ANTIBACTERIAL
Product NDC 76162-897
Requested package NDC 76162-897-03
11-digit product format 761620897
Labeler code 76162
Product ID 76162-897_4c9c50bd-ccb6-b49e-e063-6394a90aec6d
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride soap
Dosage form LIQUID
Route TOPICAL
Labeler Topco Associates LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-18
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL
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 76162-897-03 ANTIBACTERIAL 1478 mL in 1 BOTTLE, PLASTIC LIQUID 1478 3 76162-897-96 ANTIBACTERIAL 221 mL in 1 BOTTLE, PLASTIC LIQUID 221 3
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 76162-897-03 76162089703 1478 mL in 1 BOTTLE, PLASTIC (76162-897-03) 1478 ml 2025-12-18 No No Current