Home NDC 55319-879 Benzalkonium Chloride
Product NDC 55319-879
11-digit product format 553190879
Labeler code 55319
Product ID 55319-879_4a8e790e-8071-fa73-e063-6394a90a8a7a
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form GEL
Route TOPICAL
Labeler Family Dollar Stores, Inc
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-03
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 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 55319-879-03 Benzalkonium Chloride 1470 mL in 1 BOTTLE, PLASTIC GEL 1470 2
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 55319-879-03 55319087903 1470 mL in 1 BOTTLE, PLASTIC (55319-879-03) 1470 ml 2025-06-03 No No Current