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 92 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join germstarCitrus ETHYL ALCOHOL Soaptronic, LLC 779abef7-53ff-47c3-b7e6-27570eb055b3 2024-12-19 Warnings Exact identifier application number: M003 germstarGel ETHYL ALCOHOL Soaptronic, LLC b5fd6c3c-d452-74e6-e053-2995a90a9090 2024-12-19 Warnings Exact identifier application number: M003 Isopropyl alcohol 91 percent ISOPROPYL ALCOHOL Jell Pharmaceuticals Pvt. Ltd. cd98812b-017a-2cd2-e053-2a95a90a38ce 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 50% ISOPROPYL ALCOHOL MY IMPORTS LLC d4d72406-067d-1f67-e053-2995a90a1a9f 2024-12-18 Warnings Exact identifier application number: M003 AMORAY 70% ISOPROPYL RUBBING ALCOHOL ISOPROPYL ALCOHOL MY IMPORT USA INC 7114b527-106b-4629-867c-63dba13635a2 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7e7f8-7c8a-2b51-e053-2995a90a63d0 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL My Imports USA, LLC d4d77ec3-4930-74f0-e053-2a95a90a962a 2024-12-18 Warnings Exact identifier application number: M003 91% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d7adaf-c0fd-82fa-e053-2995a90ab9f6 2024-12-18 Warnings Exact identifier application number: M003 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA, LLC de47bf08-f64e-781d-e053-2a95a90ab08f 2024-12-18 Warnings Exact identifier application number: M003 AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL MY IMPORTS USA LLC d4d80ae4-3fba-4605-e053-2a95a90a2119 2024-12-18 Warnings Exact identifier application number: M003 American Red Cross 50% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL MY IMPORTS USA LLC de47a879-9cd0-5fbb-e053-2a95a90a1fba 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5ee961-1d64-0d9d-e053-2a95a90a6010 2024-12-18 Warnings Exact identifier application number: M003 70% Isopropyl Rubbing Alcohol ISOPROPYL ALCOHOL SZY Holdings, LLC dba EverReady First Aid 1e39b0f4-66d1-47ac-aed6-d6ac019888ce 2024-12-18 Warnings Exact identifier application number: M003 RUBBING ALCOHOL ALCOHOL INTERNATIONAL GENERAL TRADING CORP bd5eb0df-cd2d-691c-e053-2995a90a2511 2024-12-18 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL First Aid Research Corp. 7d1c0382-31b3-48d0-a514-c5cc45a2299e 2024-12-18 Warnings Exact identifier application number: M003 First Aid Only First Aid-Burn BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE Acme United Corporation f31a44ff-e4ac-de1e-e053-2a95a90ab036 2024-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer (Lavender Rosemary) HAND SANITIZER SPRAY Tubby Todd 2992a52a-21a9-18be-e063-6294a90a834d 2024-12-18 Warnings Exact identifier application number: M003 CVS Decolorized Iodine ALCOHOL CVS Pharmacy d9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd 2024-12-18 Warnings Exact identifier application number: M003 De La Cruz Decolorized Iodine ETHYL ALCOHOL DLC Laboratories, Inc. 5d8f6aaa-0b87-1166-e053-2991aa0a297f 2024-12-18 Warnings Exact identifier application number: M003 Humco Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 1e078022-f32c-48bd-8add-f83aebcc5812 2024-12-18 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