Home NDC 71020-004-64 Antibacterial
Product NDC 71020-004
Requested package NDC 71020-004-64
11-digit product format 710200004
Labeler code 71020
Product ID 71020-004_2abd8abc-4e8c-774a-e063-6394a90a23de
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form LIQUID
Route TOPICAL
Labeler Sante Manufacturing Inc
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-10-08
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Antibacterial
Listing expiration 2026-12-31 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71020-004-64 Antibacterial 1900 mL in 1 BOTTLE, PLASTIC LIQUID 1900 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71020-004 ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [SANTE MANUFACTURING INC] 5 Current NDC, Legacy NDC, 1 package rows 20250105_3e64d344-8883-0235-e054-00144ff8d46c.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 Marketing end Sample Exclude flag Status 71020-004-64 71020000464 1900 mL in 1 BOTTLE, PLASTIC (71020-004-64) 1900 ml 2016-10-08 0000-00-00 No No Current