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 103 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb77267-73ad-efd2-e063-6294a90a43f7 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb7d6ca-ef7e-5225-e063-6294a90aa692 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Sweet pea 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc8a756-852f-6cf8-e063-6394a90a57e6 2024-07-08 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Vanilla 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1cc90b2f-450f-1deb-e063-6394a90a6480 2024-07-08 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb4316d-c8c6-3fa2-e063-6394a90a23d2 2024-07-07 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd f531053d-82e4-7613-e053-2995a90a349f 2024-07-02 Warnings Exact identifier application number: M003 Antibacterial Hand Sanitizer ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd 1ae5c268-1834-4ac2-931e-bb7fd0088cd2 2024-07-02 Warnings Exact identifier application number: M003 Quality Choice ISOPROPYL ALCOHOL Chain Drug Marketing Association Inc 1262c5d7-63ef-f1c1-e063-6294a90a1f0f 2024-07-02 Warnings Exact identifier application number: M003 Genuine First Aid Antiseptic Towelette BENZALKONIUM CHLORIDE GFA Production (Xiamen) Co., Ltd. dfff78d2-e23c-40b2-8a49-8f4140bb0df6 2024-06-25 Warnings Exact identifier application number: M003 Walgreens 3 Hydrogen Peroxide Wipes HYDROGEN PEROXIDE Walgreen Company 03c497cc-c8b1-43b7-86ba-f9f9fc7432bf 2024-06-18 Warnings Exact identifier application number: M003 Antimicrobial BODY CLEANSER McKesson 8ff06cea-3427-5b40-e053-2995a90a0634 2024-06-17 Warnings Exact identifier application number: M003 Swabs ISOPROPYL ALCOHOL McKesson 4650c945-8e38-5ad9-e054-00144ff8d46c 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER COCONUT BREEZE ALCOHOL SCENT THEORY PRODUCTS LLC 1a5152b3-d674-f69a-e063-6394a90a6cac 2024-06-07 Warnings Exact identifier application number: M003 HAND SANITIZER REBEL CHERRY ALCOHOL SCENT THEORY PRODUCTS LLC 1a503858-4d2f-8e32-e063-6294a90ade97 2024-06-07 Warnings Exact identifier application number: M003 Antiseptic Wipe BENZALKONIUM CHLORIDE Jianerkang Medical Co., Ltd 1a3c5fc9-70cc-e857-e063-6294a90a3424 2024-06-06 Warnings Exact identifier application number: M003 Hydrogen Peroxide HYDROGEN PEROXIDE Wildman Business Group 1f95b277-e40c-4a17-e063-6294a90a1127 2024-06-01 Warnings Exact identifier application number: M003 Hand Sanitizer ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. dbfdecf0-a961-4cc5-bf87-ae30bbc302dd 2024-05-31 Warnings Exact identifier application number: M003 hand sanitizer 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a6c3c6-4b27-9011-e063-6394a90ae512 2024-05-30 Warnings Exact identifier application number: M003 antibacterial hand sanitizer gel 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 19a7b2fc-239c-b53c-e063-6394a90a0906 2024-05-30 Warnings Exact identifier application number: M003 MyMedic Hydrocortisone HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. 197fc623-2fb9-184c-e063-6394a90a4104 2024-05-28 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