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 73 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AshleyBelle Moisturizing Hand Sanitizer Mango Peach Splash ETHYL ALCOHOL MY IMPORTS USA LLC 3a2a4539-30eb-7451-e063-6294a90a2c22 2025-07-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Sweet Floral Morning ETHYL ALCOHOL MY IMPORTS USA LLC 3a2a4fab-6776-7359-e063-6294a90a8524 2025-07-17 Warnings Exact identifier application number: M003 AshleyBelle Moisturizing Hand Sanitizer Coconut Sandalwood ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 3a186822-025c-6970-e063-6394a90a5dc1 2025-07-16 Warnings Exact identifier application number: M003 X3 Clean Hand Sanitizer BENZALKONIUM CHLORIDE Natural Essentials, Inc. 5a0aea16-b1ff-4fa1-a292-0f1447474593 2025-07-15 Warnings Exact identifier application number: M003 Meridian Wrapped antibacterial deodorant BENZETHONIUM CHLORIDE Bob Barker Company Inc. 84aada12-f26e-4dc9-a256-8746c6431f61 2025-07-15 Warnings Exact identifier application number: M003 Meridian Unwrapped antibacterial deodorant BENZETHONIUM CHLORIDE Bob Barker Company Inc. 2c124769-a044-4d62-9325-89d5310a42de 2025-07-15 Warnings Exact identifier application number: M003 Isopropyl alcohol ISOPROPYL ALCOHOL AmerisourceBergen (Good Neighbor Pharmacy) 46122 5539cbe8-1d0f-41f8-9c5d-a9af7f28eed1 2025-07-15 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 39a417a8-afec-f893-e063-6394a90a70ae 2025-07-11 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 39a4aecf-1e74-4589-e063-6394a90a34fb 2025-07-11 Warnings Exact identifier application number: M003 HAND SANITIZER ALCOHOL ANTISEPTIC Kingkey MBC Life Technology Group Co.,Ltd 39a57c83-5ea6-5b36-e063-6294a90a284d 2025-07-11 Warnings Exact identifier application number: M003 terrasil First Aid Antiseptic Wound and Burn Care HEXYLRESORCINOL Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 3cfa43a0-402b-4b32-94ff-2b2e2e6565c2 2025-07-11 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Cardinal Health (Leader) 70000 bf355e30-ad2f-4f93-9d77-8efd6a908e58 2025-07-11 Warnings Exact identifier application number: M003 Isopropyl Rubbing Alcohol 70 Percent Wintergreen ISOPROPYL ALCOHOL Best Choice (Valu Merchandisers Company) abcc7941-e521-4ad6-89df-0b965b634eb3 2025-07-11 Warnings Exact identifier application number: M003 Isopropyl Alcohol ISOPROPYL ALCOHOL Cardinal Health (Leader) 70000 5ffa8ecf-1349-4758-8d47-e9a96d2ddaee 2025-07-11 Warnings Exact identifier application number: M003 XTRA Antibacterial Hand Fresh Lemon BENZALKONIUM CHLORIDE MY IMPORTS USA LLC. 39904847-ed55-f4a3-e063-6294a90a85a1 2025-07-10 Warnings Exact identifier application number: M003 XTRA Squeeze Antibacterial Hand Fresh Lemon BENZALKONIUM CHLORIDE Zhejiang Jifu Daily Chemical Co., Ltd. 397a897a-baab-d209-e063-6294a90aac65 2025-07-10 Warnings Exact identifier application number: M003 XTRA Antibacterial Hand Fresh Lemon BENZALKONIUM CHLORIDE Zhejiang Jifu Daily Chemical Co., Ltd. 398fd961-d5e6-9d40-e063-6294a90a5be5 2025-07-10 Warnings Exact identifier application number: M003 XTRA Squeeze Antibacterial Hand Fresh Lemon BENZALKONIUM CHLORIDE MY IMPORTS USA LLC. 39901012-e1a1-c6e3-e063-6294a90ab41f 2025-07-10 Warnings Exact identifier application number: M003 Aerowipe ALCOHOL WIPE Aero Healthcare 34c93704-9f3c-6746-e054-00144ff8d46c 2025-07-10 Warnings Exact identifier application number: M003 Walgreens 10 Povidone-Iodine Solution POVIDONE-IODINE WALGREEN COMPANY a7b635d0-9109-4cd6-9b96-fba0d76464fc 2025-07-10 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