Home NDC 59640-321 Benzalkonium Chloride
Product NDC 59640-321
11-digit product format 596400321
Labeler code 59640
Product ID 59640-321_56aa852a-2946-3ec8-e063-6394a90a4515
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form LIQUID
Route TOPICAL
Labeler H E B
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-15
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 Benzalkonium Chloride
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59640-321-96 59640032196 221 mL in 1 BOTTLE, PUMP (59640-321-96) 221 ml 2026-07-15 No No Current