Home NDC 75712-416 Benzalkonium chloride
Product NDC 75712-416
11-digit product format 757120416
Labeler code 75712
Product ID 75712-416_4c0f997d-d3ca-c39e-e063-6294a90ae38d
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride
Dosage form LIQUID
Route TOPICAL
Labeler Old East Main Co.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-02
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 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 75712-416-96 Benzalkonium chloride 221 mL in 1 BOTTLE, PUMP LIQUID 221 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 75712-416-96 75712041696 221 mL in 1 BOTTLE, PUMP (75712-416-96) 221 ml 2026-01-02 No No Current