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 110 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join sunmark Povidone-Iodine Topical POVIDONE-IODINE Strategic Sourcing Services LLC acc349d6-2875-4814-aa6e-828fffec7f07 2023-12-19 Warnings Exact identifier application number: M003 DDM Iodine Tincture Mild IODINE AND SODIUM IODIDE AND ALCOHOL Discount Drug Mart 5d538c8e-bf87-d85c-e053-2991aa0af729 2023-12-19 Warnings Exact identifier application number: M003 DDM Decolorized Iodine ETHYL ALCOHOL Discount Drug Mart 5d570ea7-ab08-54b7-e053-2991aa0a7a83 2023-12-19 Warnings Exact identifier application number: M003 DDM Povidone Iodine POVIDONE IODINE 10% Discount Drug Mart 5d161a9d-0462-0afd-e053-2991aa0a22e2 2023-12-19 Warnings Exact identifier application number: M003 HEB Povidone Iodine POVIDONE IODINE 10% H E B 5d576ce2-7d63-c860-e053-2a91aa0a072c 2023-12-18 Warnings Exact identifier application number: M003 Publix Povidone Iodine POVIDONE IODINE 10% Publix 5d6bba46-2571-4957-e053-2a91aa0a2e85 2023-12-18 Warnings Exact identifier application number: M003 Top Care Decolorized Iodine ETHYL ALCOHOL TOPCO ASSOCIATES LLC 5d6bdc17-5c3a-7dec-e053-2991aa0aa450 2023-12-18 Warnings Exact identifier application number: M003 Tincture Merthiolate BENZALKONIUM CHLORIDE DLC Laboratories, Inc 4fec9119-fbbf-4fc7-9122-c6300cac8731 2023-12-18 Warnings Exact identifier application number: M003 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN ISOPROPYL ALCOHOL New Pride Corp 0c9e1e9c-b8fc-1932-e063-6394a90a09bf 2023-12-16 Warnings Exact identifier application number: M003 DermaWound Wound Care POVIDONE-IODINE Progressive Doctors, LLC 2d49daa7-aa02-4219-880b-e1697bde8a7e 2023-12-15 Warnings Exact identifier application number: M003 Ethyl Rubbing Alcohol ALCOHOL Humco Holding Group, Inc. 829f3e16-7a9b-4da7-87d2-f58254bda721 2023-12-15 Warnings Exact identifier application number: M003 Humco Iodides Tincture ETHYL ALCOHOL Humco Holding Group, Inc. d230e3a2-1cde-44a9-82c3-3dc5474b3a72 2023-12-15 Warnings Exact identifier application number: M003 Humco Hydrogen Peroxide HYDROGEN PEROXIDE 3% Humco Holding Group, Inc. 2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% ISOPROPYL ALCOHOL Humco Holding Group, Inc. c220b916-6914-435f-84e2-ba828c9916b1 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack ISOPROPYL ALCOHOL Humco Holding Group, Inc. 8de61fdd-8bb9-4845-9129-97bed0686a68 2023-12-15 Warnings Exact identifier application number: M003 HUMCO Merthiolate BENZALKONIUM CHLORIDE Humco Holding Group, Inc. 864063a5-c6cc-4657-9cd6-51af4673bf98 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE SPRAY 5% Humco Holding Group, Inc. a7bb80c4-bbc0-21ea-e053-2995a90a52c1 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE 10% Humco Holding Group, Inc. 6064c23b-7c15-208d-e053-2991aa0a00f6 2023-12-15 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE IODINE GARGLE 0.5% Humco Holding Group, Inc. a7b9ad55-cfeb-6066-e053-2a95a90af975 2023-12-15 Warnings Exact identifier application number: M003 Rite Aid Povidone Iodine POVIDONE IODINE 10% Rite Aid Corporation 5df6ff37-a4ea-d666-e053-2991aa0a9786 2023-12-15 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