Home NDC 51628-4528 American Red Cross Antiseptic
Product NDC 51628-4528
11-digit product format 516284528
Labeler code 51628
Product ID 51628-4528_421dc19f-030c-eb14-e063-6394a90a970a
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride 0.13%(w/w)/Benzocaine 5.00%(w/w)
Dosage form SPRAY
Route TOPICAL
Labeler MY IMPORTS USA LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-27
Substance BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength 5; .13 g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 American Red Cross Antiseptic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 5 g/100g BENZALKONIUM CHLORIDE .13 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup 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 51628-4528-1 American Red Cross Antiseptic 141 g in 1 BOTTLE, SPRAY SPRAY 141 1
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 109 of 114 · 2,270 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51628-4528-1 51628452801 141 g in 1 BOTTLE, SPRAY (51628-4528-1) 141 g 2025-10-27 No No Current