Home NDC 84269-3501 Antiseptic
Product NDC 84269-3501
11-digit product format 842693501
Labeler code 84269
Product ID 84269-3501_544f5843-189c-a04b-e063-6294a90a9b78
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride, benzocaine
Dosage form SPRAY
Route TOPICAL
Labeler Wildman Business Group
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength 50; 1 mg/g; mg/g
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 Antiseptic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 50 mg/g BENZALKONIUM CHLORIDE 1 mg/g
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1245229 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 84269-3501-1 Antiseptic 60 g in 1 BOTTLE, SPRAY SPRAY 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84269-3501 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [WILDMAN BUSINESS GROUP] 1 Current NDC, 1 package rows 20240901_1fd15b91-6b81-d0bd-e063-6294a90a4d27.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 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84269-3501-1 84269350101 60 g in 1 BOTTLE, SPRAY 60 g Historical 84269-3501-2 84269350102 60 g in 1 BOTTLE, SPRAY (84269-3501-2) 60 g 2026-03-19 No No Current