Home NDC 42961-227 Xpect Antiseptic
Product NDC 42961-227
11-digit product format 429610227
Labeler code 42961
Product ID 42961-227_d7e7ee0e-159b-4040-ad6b-f40f0c639915
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride
Dosage form SPRAY
Route TOPICAL
Labeler Cintas Corporation
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-19
Substance BENZALKONIUM CHLORIDE
Active strength .13 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 Xpect Antiseptic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 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 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 42961-227-01 Xpect Antiseptic 59.1 mL in 1 BOTTLE, SPRAY SPRAY 59.1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42961-227 XPECT ANTISEPTIC (BENZALKONIUM CHLORIDE) SPRAY [CINTAS CORPORATION] 3 Current NDC, 1 package rows 20241228_d9a31a11-e80f-4ded-ad0a-34f93b01557e.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 85 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 42961-227-01 42961022701 59.1 mL in 1 BOTTLE, SPRAY (42961-227-01) 59.1 ml 2023-04-19 No No Current