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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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