Home NDC 69396-153 Antiseptic
Product NDC 69396-153
11-digit product format 693960153
Labeler code 69396
Product ID 69396-153_13f1a05a-30a4-34da-e063-6394a90a8b6a
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride 0.13%
Dosage form SPRAY
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA, LLC.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-18
Substance BENZALKONIUM CHLORIDE
Active strength 1.3 g/L
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 Antiseptic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 g/L
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 1039012 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 69396-153-02 Antiseptic 0.0591 L in 1 BOTTLE, SPRAY SPRAY 0.0591 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-153 ANTISEPTIC (BENZALKONIUM CHLORIDE 0.13%) SPRAY [TRIFECTA PHARMACEUTICALS USA, LLC.] 1 Current NDC, 1 package rows 20240322_13f1c70f-3b44-8eef-e063-6294a90af634.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 44 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69396-153-02 69396015302 .0591 L in 1 BOTTLE, SPRAY (69396-153-02) 2024-03-18 No No Current