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 98 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MED NAP Cleansing Towelette BENZALKONIUM CHLORIDE Acme United Corporation d92cd45a-234c-4872-e053-2a95a90a3e1c 2024-11-09 Warnings Exact identifier application number: M003 MED NAP Obstetrical Towelette BENZALKONIUM CHLORIDE Acme United Corporation d83d2fab-6972-9b18-e053-2995a90a5cb5 2024-11-09 Warnings Exact identifier application number: M003 MED NAP Benzalkonium Chloride Antiseptic BENZALKONIUM CHLORIDE Acme United Corporation d7c404c1-c765-a67c-e053-2995a90a6b8e 2024-11-09 Warnings Exact identifier application number: M003 Barbie BZK ANTISEPTIC WIPE BENZALKONIUM CHLORIDE Ashtel Studios, Inc. d675eb91-80a8-4874-a2b0-c2bf69264911 2024-11-08 Warnings Exact identifier application number: M003 Barbie ALCOHOL WIPE ISOPROPYL ALCOHOL Ashtel Studios, Inc. a4a6beb0-5781-4d74-9120-7ca64e035c23 2024-11-08 Warnings Exact identifier application number: M003 MARVEL ALCOHOL WIPE ISOPROPYL ALCOHOL Ashtel Studios, Inc. f6cd4757-d6e0-46bd-827f-3f380c71858f 2024-11-07 Warnings Exact identifier application number: M003 Instant Hand Sanitizer HAND SANITIZER Raining Rose, Inc. 2656d129-df88-4489-e063-6394a90a4b49 2024-11-07 Warnings Exact identifier application number: M003 HealthWise Advanced Hand Sanitizer ETHYL ALCOHOL 70% Veridian Healthcare 261bd056-c2f9-2a69-e063-6394a90af8df 2024-11-04 Warnings Exact identifier application number: M003 Hand Sanitizer Cucumber Aloe ORGANIC ETHYL ALCOHOL Whole Foods Market, Inc. 0588ae1b-f29a-e1b6-e063-6394a90a0de1 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Cucumber Aloe ETHYL ALCOHOL Whole Foods Market, Inc. 074334af-c26e-4126-e063-6394a90ae4c4 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Orange Blossom ORGANIC ETHYL ALCOHOL Whole Foods Market, Inc. 07f708d1-11c8-eb50-e063-6294a90a3a81 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 0742f251-5fc9-c015-e063-6394a90a79b1 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Orange Blossom ETHYL ALCOHOL Whole Foods Market, Inc. 07436407-7a15-7cee-e063-6294a90a9651 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. 07f7e966-e57e-dede-e063-6294a90acbf5 2024-11-02 Warnings Exact identifier application number: M003 Hand Sanitizer Lavender ETHYL ALCOHOL Whole Foods Market, Inc. ec8c7597-a3f1-65a8-e053-2995a90a69a1 2024-11-02 Warnings Exact identifier application number: M003 Lemongrass Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25ca3908-24aa-5e4f-e063-6394a90a7a88 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Decolorized Iodine ETHYL ALCOHOL Sanvall Enterprises, Inc 16c92427-84d2-cad5-e063-6394a90af435 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Mercurochrome BENZALKONIUM CHLOLRIDE Sanvall Enterprises, Inc 16c6c2f0-0f08-e640-e063-6394a90aa01d 2024-10-31 Warnings Exact identifier application number: M003 Sanar Naturals Gentian Violet GENTIAN VIOLET Sanvall Enterprises, Inc 1922518d-e49b-5010-e063-6394a90a9112 2024-10-31 Warnings Exact identifier application number: M003 Lavender Hand Sanitizer ALCOHOL Natural Essentials, Inc. 25cada8c-8c80-c140-e063-6294a90a3336 2024-10-31 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