Home NDC 61010-5300 Antiseptic
Product NDC 61010-5300
11-digit product format 610105300
Labeler code 61010
Product ID 61010-5300_10d37ff3-97c6-9f55-e063-6294a90a656b
Type HUMAN OTC DRUG
Nonproprietary name benzalkonium chloride, benzocaine
Dosage form SPRAY
Route TOPICAL
Labeler Safetec of America, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-15
Substance BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength 1; 50 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 BENZALKONIUM CHLORIDE 1 mg/g BENZOCAINE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup U3RSY48JW5 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5300-0 Antiseptic 60 g in 1 BOTTLE, SPRAY SPRAY 60 4 61010-5300-2 Antiseptic 90 g in 1 BOTTLE, SPRAY SPRAY 90 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded benzalkonium chloride ACTIVE INGREDIENT F5UM2KM3W7 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 benzocaine ACTIVE INGREDIENT U3RSY48JW5 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 benzalkonium ACTIVE MOIETY 7N6JUD5X6Y ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 benzocaine ACTIVE MOIETY U3RSY48JW5 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5300 ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240214_458e65f2-826d-4550-8c7d-17add2d7ba9a.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 77 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AshleyBelle Moisturizing Hand Sanitizer Spearmint Eucalyptus ETHYL ALCOHOL 70% MY IMPORTS USA LLC 36b6d0e4-8d9f-9df5-e063-6294a90af326 2025-06-03 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sunflower Haze ETHYL ALCOHOL 70% MY IMPORTS USA LLC 36b71ebe-0638-73e8-e063-6394a90a9f4e 2025-06-03 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Vanilla Cashmere ETHYL ALCOHOL 70% MY IMPORTS USA LLC 36b73e99-293a-865b-e063-6394a90a39c4 2025-06-03 Warnings Exact identifier application number: M003 Biopure 3 Hydrogen Peroxide HYDROGEN PEROXIDE Quest USA Corp 1e34d066-f82c-484c-87bf-aa54fb1fac07 2025-06-02 Warnings Exact identifier application number: M003 Simply Saline Wound Care BENZETHONIUM CHLORIDE 0.13% Church & Dwight Co., Inc. 6c802e91-b69e-cdd0-e053-2991aa0aa781 2025-06-01 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 39a5a4a2-983e-a4e7-e063-6394a90aa27c 2025-06-01 Warnings Exact identifier application number: M003 BerbereX Wound Cleanser BENZETHONIUM CHLORIDE Cosco International, Inc. 08b28f52-21fc-4694-a163-91c8193b4008 2025-05-30 Warnings Exact identifier application number: M003 Op-First Aid Series Povidone Iodine Prep Pad POVIDONE-IODINE Yiwu Ori-Power Medtech Co.,Ltd. 32dc994b-6636-72d8-e063-6294a90a98f6 2025-05-29 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Apple Pear Clove ETHYL ALCOHOL 70% Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 363e549a-c432-9f2e-e063-6394a90ae886 2025-05-28 Warnings Exact identifier application number: M003 Quality Choice Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Chain Drug Marketing Association, Inc c2822eb6-8a2a-4337-acce-6f7fc8496175 2025-05-26 Warnings Exact identifier application number: M003 VLITEPRO First Aid Wipes ISOPROPYL ALCOHOL CLOTH Yiwu Ori-Power Medtech Co., Ltd. 35a7873a-e340-aae3-e063-6294a90a767f 2025-05-26 Warnings Exact identifier application number: M003 Band Aid Antiseptic Cleansing Liquid BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE Kenvue Brands LLC d2a6e0d2-5b9b-11c0-e053-2a95a90a4df0 2025-05-26 Warnings Exact identifier application number: M003 First Aid Only Antiseptic First Aid BENZALKONIUM CHLORIDE Acme United Corporation 35d06b38-55dd-e306-e063-6394a90aaf26 2025-05-23 Warnings Exact identifier application number: M003 BIOPURE20CT ANTI BACTERIAL HAND WIPES BENZALKONIUM CHLORIDE Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. 359f43c7-682a-ba1c-e063-6394a90a8dcb 2025-05-21 Warnings Exact identifier application number: M003 Walgreens Advanced Wound Wash BENZALKONIUM CHLORIDE Walgreens Co. 25c6d81c-d462-5a89-e063-6294a90a08f3 2025-05-20 Warnings Exact identifier application number: M003 Hand Sanitizer Cozy Comfort ALCOHOL Scent Theory Products LLC 35965496-d101-c604-e063-6294a90a1a48 2025-05-20 Warnings Exact identifier application number: M003 Hand Sanitizer Whipped Chai ALCOHOL Scent Theory Products LLC 35966f42-1f59-e5f5-e063-6294a90a9982 2025-05-20 Warnings Exact identifier application number: M003 VLITEPRO BZK Antiseptic Towelette BENZALKONIUM CHLORIDE Yiwu Ori-Power Medtech Co.,Ltd. 3543d2f6-16d3-aa65-e063-6294a90a9637 2025-05-19 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Safeway, Inc. 29e5c152-15d7-4080-abf0-f76f8e9cbf5a 2025-05-16 Warnings Exact identifier application number: M003 Signature Care Advanced Hand Sanitizer ALCOHOL Yiwu Yangjie Daily Chemicals Co.,Ltd. db649f36-04b9-47f3-a334-94d3247f80de 2025-05-16 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 Marketing end Sample Exclude flag Status 61010-5300-0 61010530000 60 g in 1 BOTTLE, SPRAY (61010-5300-0) 60 g 2012-02-15 0000-00-00 No No Current 61010-5300-2 61010530002 90 g in 1 BOTTLE, SPRAY (61010-5300-2) 90 g 2012-02-15 0000-00-00 No No Current