Home NDC 51628-4439 XTRA
Product NDC 51628-4439
11-digit product format 516284439
Labeler code 51628
Product ID 51628-4439_2fb7084c-c45d-3832-e063-6394a90a8b0c
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SPRAY
Route TOPICAL
Labeler MY IMPORTS USA LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-27
Substance BENZALKONIUM CHLORIDE
Active strength .13 g/100mL
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 XTRA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100mL
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 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 51628-4439-1 XTRA 399 mL in 1 BOTTLE, SPRAY SPRAY 399 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51628-4439 XTRA (BENZALKONIUM CHLORIDE) SPRAY [MY IMPORTS USA LLC] 3 Current NDC, 1 package rows 20250309_27f4ff15-5480-8842-e063-6294a90ad35b.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 9 of 114 · 2,277 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51628-4439-1 51628443901 399 mL in 1 BOTTLE, SPRAY (51628-4439-1) 399 ml 2024-11-27 No No Current