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 94 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Englewood Amenity BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 7c9ce1bf-6aa2-4073-ad09-2ddf845102a2 2024-12-17 Warnings Exact identifier application number: M003 Mentholatum Moisturizing Hand Sanitizer BENZALKONIUM CHLORIDE The Mentholatum Company 365c93bc-2299-4e69-ba3a-69414bfe78d7 2024-12-13 Warnings Exact identifier application number: M003 Curaplex Alcohol Prep Pad ISOPROPYL ALCOHOL Sarnova, Inc. da1a4baa-05eb-4a75-82bb-39c547daef64 2024-12-12 Warnings Exact identifier application number: M003 Foaming Hand Sanitizer ALCOHOL Empack Spraytech Inc. 8bb072f2-9cd4-499d-9d7f-7166451b8f20 2024-12-12 Warnings Exact identifier application number: M003 Extra Stength Hand Sanitizer Zytec Germ Buster ALCOHOL 80%W/W Empack Spraytech Inc. da854195-3a50-4fae-a5ea-183bf524c973 2024-12-12 Warnings Exact identifier application number: M003 Zytec Hand Sanitizer Wipes 80% w/w Alcohol ALCOHOL Empack Spraytech Inc. ab86fd0c-40cd-0bb6-e053-2a95a90a76e2 2024-12-12 Warnings Exact identifier application number: M003 Dermoplast Kids First Aid BENZETHONIUM CHLORIDE AND BENZOCAINE Advantice Health, LLC. 29a18018-5214-4080-ac40-e646319e95ce 2024-12-12 Warnings Exact identifier application number: M003 New Skin Bandage BENZETHONIUM CHLORIDE Advantice Health, LLC. 5846f414-8329-4034-b99f-92721bdb3d14 2024-12-12 Warnings Exact identifier application number: M003 CVS Hand Sanitizer ALCOHOL CVS b5faeb31-67c7-2000-e053-2995a90a1409 2024-12-10 Warnings Exact identifier application number: M003 NEXXGEN 70% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 8d1a5c98-8169-4f40-8601-a6f6bbbbebe7 2024-12-09 Warnings Exact identifier application number: M003 NEXXGEN 91% RUBBING ALCOHOL with Wintergreen ISOPROPYL ALCOHOL A & A Nexxgen LLC 12b8c85a-da0c-47a1-9531-c9f2858c4f31 2024-12-09 Warnings Exact identifier application number: M003 NEXXGEN 91% RUBBING ALCOHOL ISOPROPYL ALCOHOL A & A Nexxgen LLC 609267da-3ee6-4bd3-aecf-610d9047774c 2024-12-09 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Sarnova, Inc. 62be13a6-da24-4ab0-b0f4-f2894324c20c 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic ALCOHOL ASP Global b84075db-be0c-4265-b262-825bc6ade9d8 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic BENZALKONIUM CHLORIDE ASP Global 47276148-08e5-400e-94ac-d2d9db423b51 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic ALCOHOL ASP Global 9aca3f89-cdde-430c-8eb6-43a3ac3fc0df 2024-12-06 Warnings Exact identifier application number: M003 Instant Hand Antiseptic BENZALKONIUM CHLORIDE ASP Global 4eef4b0f-9209-45a4-8a0e-7891fc380fe5 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 2998b2bd-6208-4cb4-982b-0ffb97d7d75d 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. 68003c71-5959-476f-b252-1f131e9305e2 2024-12-05 Warnings Exact identifier application number: M003 MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 BENZETHONIUM CHLORIDE Yangzhou H&R Plastic Daily Chemical Co., Ltd. e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc2 2024-12-05 Warnings Exact identifier application number: M003
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