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 48 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Freshnap Plus - 80% Ethyl Alcohol Towelette ALCOHOL TOWELETTE KARI-OUT LLC f4ae66e3-323b-5e2e-e053-2995a90acf42 2025-12-27 Warnings Exact identifier application number: M003 Guardelle BENZALKONIUM CHLORIDE Social Medical Supply LLC 8793e3be-7409-4f71-9397-abbeacd27cf8 2025-12-22 Warnings Exact identifier application number: M003 CareALL First Aid Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCL New World Imports, Inc 69eef888-0044-485c-96a1-247ed1204858 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Pear Blossom Tea ALCOHOL SOLUTION Noshinku 46927edb-f8be-f0b9-e063-6294a90a8e56 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Santal Blanc ALCOHOL SOLUTION Noshinku 4692c807-268e-6477-e063-6394a90aac0a 2025-12-22 Warnings Exact identifier application number: M003 Hand Sanitizer Vanilla Creme ALCOHOL SOLUTION Noshinku 4692e68c-2bc8-83f8-e063-6294a90a84e4 2025-12-22 Warnings Exact identifier application number: M003 Alcohol sanitizer wipes ALCOHOL/PURIFIED WATER SHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD. ab9634bd-4226-2f73-e053-2995a90a802f 2025-12-19 Warnings Exact identifier application number: M003 Sanitizing Wipes BENZALKONIUM CHLORIDE Wipes LLC 9e9a76d9-23e0-4d3a-9903-8bf7aba54aa3 2025-12-19 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. afeccd10-c7e5-6193-e053-2995a90a9a5a 2025-12-18 Warnings Exact identifier application number: M003 Hand Sanitizer BENZALKONIUM CHLORIDE DGH Pharma, Inc. ae4311f8-fc40-38a7-e053-2a95a90ae829 2025-12-18 Warnings Exact identifier application number: M003 Alcohol ALCOHOL Dynarex Corporation 88c5dcbe-185f-4966-b98b-25d50299e8df 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fc8cb10c-4973-c0bd-e053-6394a90a6fdb 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf27cbf-9535-1356-e053-6394a90a0362 2025-12-18 Warnings Exact identifier application number: M003 Povidone Iodine POVIDONE-IODINE TwinMed LLC fcf30b3a-c25b-7aaf-e053-6394a90affda 2025-12-18 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ab5e8-029a-fe9d-e063-6294a90ac14d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462ad5ba-253f-2a30-e063-6294a90a261d 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Honeydew Tart ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 462af072-6709-546f-e063-6294a90aacc8 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Pear Blossom ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b1d38-c7fa-992f-e063-6294a90ab78f 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Black Raspberry ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b2d3f-67b0-c393-e063-6294a90a208a 2025-12-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Clementine Burst ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 462b36d0-0a1f-bda8-e063-6294a90a5792 2025-12-17 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