Home NDC 11344-628 Benzalkonium chloride
Product NDC 11344-628
11-digit product format 113440628
Labeler code 11344
Product ID 11344-628_4cea8e9e-19ba-4588-e063-6394a90af763
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride
Dosage form LIQUID
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-12-20
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-628-03 Benzalkonium chloride 1470 mL in 1 BOTTLE, PLASTIC LIQUID 1470 18 11344-628-45 Benzalkonium chloride 946 mL in 1 BOTTLE, PLASTIC LIQUID 946 18 11344-628-57 Benzalkonium chloride 1180 mL in 1 BOTTLE, PLASTIC LIQUID 1180 18 11344-628-96 Benzalkonium chloride 221 mL in 1 BOTTLE, PLASTIC LIQUID 221 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-628 BENZALKONIUM CHLORIDE LIQUID [CONSUMER PRODUCT PARTNERS, LLC] 17 Current NDC, 4 package rows 20250216_e368e7b8-9695-4dd8-a49b-8c17c24c7f51.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 11344-628-03 11344062803 1470 mL in 1 BOTTLE, PLASTIC 1470 ml Historical 11344-628-45 11344062845 946 mL in 1 BOTTLE, PLASTIC (11344-628-45) 946 ml 2016-12-20 No No Historical 11344-628-57 11344062857 1180 mL in 1 BOTTLE, PLASTIC 1180 ml Historical 11344-628-96 11344062896 221 mL in 1 BOTTLE, PLASTIC (11344-628-96) 221 ml 2016-12-20 No No Historical