Home NDC 68016-866 Benzalkonium chloride
Product NDC 68016-866
11-digit product format 680160866
Labeler code 68016
Product ID 68016-866_4a1a0553-c314-c127-e063-6394a90aacb5
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium chloride
Dosage form LIQUID
Route TOPICAL
Labeler Pharmacy Value Alliance, LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-29
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-866-45 Benzalkonium chloride 946 mL in 1 BOTTLE, PLASTIC LIQUID 946 4 68016-866-96 Benzalkonium chloride 221 mL in 1 BOTTLE, PLASTIC LIQUID 221 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-866 BENZALKONIUM CHLORIDE LIQUID [PHARMACY VALUE ALLIANCE, LLC] 3 Current NDC, 2 package rows 20250515_5f9521f2-53f2-4d7e-9116-36e94e2d0695.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 68016-866-45 68016086645 946 mL in 1 BOTTLE, PLASTIC (68016-866-45) 946 ml 2023-06-29 No No Current 68016-866-96 68016086696 221 mL in 1 BOTTLE, PLASTIC (68016-866-96) 221 ml 2023-06-29 No No Current