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 75 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Smart Care Hand Sanitizer - Sweet Citrus ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38863865-9361-fd1a-e063-6394a90a84f4 2025-06-26 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Squishmallows Patty ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38613f78-8480-637d-e063-6394a90a4ef3 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Barbie ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38626ced-5644-9f82-e063-6294a90ac7a1 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Pistachio Brule ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 38715507-d881-d8b3-e063-6394a90ad348 2025-06-25 Warnings Exact identifier application number: M003 Smart Care Hand Sanitizer - Juicy Berry ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 3871ec77-de30-0c89-e063-6394a90a9e7a 2025-06-25 Warnings Exact identifier application number: M003 Meijer Hydrating Power Mist Hand Sanitizer- Gingerbread ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 384c26c8-7f2d-8c3a-e063-6394a90aa908 2025-06-24 Warnings Exact identifier application number: M003 Good Neighbor Pharmacy Alcohol Antiseptic Skin Cleanser ISOPROPYL ALCOHOL Amerisouce Bergen fc28cf11-afb9-4295-bee3-735ab10f6bbc 2025-06-24 Warnings Exact identifier application number: M003 Meret Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd. 385def83-38fe-df7f-e063-6394a90abbf0 2025-06-24 Warnings Exact identifier application number: M003 Antibacterial Hand Wipe ANTIBACTERIAL HAND WIPE Fujian Yifa Healthcare Products Co., Ltd. 38381a41-db33-45c6-e063-6394a90a2317 2025-06-23 Warnings Exact identifier application number: M003 Benzethonium chloride Plus Dyclonine hydrochloride LIQUID BANDAGE Rite Aid Corporation 1069226f-dfd0-4028-a033-30fa4b1e835e 2025-06-21 Warnings Exact identifier application number: M003 Cart Wipes Clean Sanitizing Wipes BENZALKONIUM CHLORIDE Carts and Parts INC. 6a8433e8-7b96-44ce-b8e2-c60575898dab 2025-06-18 Warnings Exact identifier application number: M003 WISH RUBBING ALCOHOL 99% ISOPROPYL ALCOHOL LJ Pharma a06953d7-d685-45ac-b1c6-e66dc7a05bca 2025-06-18 Warnings Exact identifier application number: M003 Sweet Orange Bergamot and Aloe ETHYL ALCOHOL ALO New York LLC 31cecf1e-1d6b-0033-e063-6294a90a7b8e 2025-06-18 Warnings Exact identifier application number: M003 POVIDONE-IODINE POVIDONE-IODINE Acme United Corporation 37c709ae-ef37-0b46-e063-6394a90af861 2025-06-17 Warnings Exact identifier application number: M003 Universal 70% Rubbing Alcohol with Wintergreen and Glycerin ISOPROPYL ALCOHOL Universal Distribution Center LLC 1fdff866-f534-4c16-b755-b2efd1e6e837 2025-06-17 Warnings Exact identifier application number: M003 WISH RUBBING ALCOHOL 99% WINTERGREEN ISOPROPYL ALCOHOL LJ Pharma de7b2253-7f36-4a27-8838-442ec635f69b 2025-06-16 Warnings Exact identifier application number: M003 WISH RUBBING ALCOHOL 70% WINTERGREEN ISOPROPYL ALCOHOL LJ Pharma 98ebf7a7-7c13-4feb-90b5-21cc6dab99f6 2025-06-16 Warnings Exact identifier application number: M003 Lacura Moisturizing Hand Sanitizer ETHYL ALCOHOL 62% Aldi dafa52fe-42e6-2c21-e053-2995a90a413f 2025-06-13 Warnings Exact identifier application number: M003 Refresher ALCOHOL Jao Limited 1debc8ca-2ea4-40c3-ad1e-8c1dc763d0f8 2025-06-13 Warnings Exact identifier application number: M003 Povidone Iodine Prep POVIDONE IODINE Sion Biotext Medical Ltd 34769116-2520-f862-e063-6394a90a5949 2025-06-11 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