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 105 of 114 · 2,275 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HCI Trifecta Pharmaceuticals USA LLC 1308ce91-2858-310a-e063-6394a90a6810 2024-03-06 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Cocoa Butter ETHYL ALCOHOL Rejoice International, Inc. 97dee45e-53be-4b37-a427-fc24388c0e05 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer Aloe Vera ETHYL ALCOHOL Rejoice International, Inc. 1e28454c-f5d8-4d6e-91f9-bc4501b027c1 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Clear ETHYL ALCOHOL Rejoice International, Inc. f0e637d9-d61e-466d-9e05-f906639dbaca 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer ETHYL ALCOHOL Rejoice International, Inc. 07b163e4-8f67-44e7-b5ef-f237023080e0 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Ice Clear ETHYL ALCOHOL Rejoice International, Inc. 605ec88a-2f4c-4716-8522-eb2748b43398 2024-02-28 Warnings Exact identifier application number: M003 Instant Hand Sanitizer - Original ETHYL ALCOHOL Rejoice International, Inc. bb9cc886-275e-4996-99dc-529f928b4905 2024-02-28 Warnings Exact identifier application number: M003 Liquid Hand Cleanse TRICLOSAN Rejoice International, Inc. 23ff5450-8308-41c0-9052-1ac4c4433d6c 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Original TRICLOSAN Rejoice International, Inc. b5ce6663-fe82-4da1-923e-acea293d7a00 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate TRICLOSAN Rejoice International, Inc. b68a7d64-2650-4fc6-a89e-05de9098a2a3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Antibacterial Hand Cleanse Mountain Spring TRICLOSAN Rejoice International, Inc. c31723d5-a313-448a-8b69-ca5f8dec25ed 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom BENZALKONIUM CHLORIDE Rejoice International a9a1467c-abcc-4ccb-88f6-430279609788 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom BENZALKONIUM CHLORIDE Rejoice International 9fa9d955-7167-4a0a-935b-2a600f439eb0 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower BENZALKONIUM CHLORIDE Rejoice International 157a14bf-f46e-49f8-96f4-a6c472eb5cb8 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foaming Hand Sanitizer BENZALKONIUM CHLORIDE Rejoice International 3082cbbb-a0ed-45eb-a116-ad1c65357dd1 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast BENZALKONIUM CHLORIDE Rejoice International 45b3ca49-edb4-4840-b857-d24045494a3a 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower BENZALKONIUM CHLORIDE Rejoice International 4890f81e-7994-4ea2-9412-5614c405a2a3 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Foam Antibacterial Hand Wash Wild Berry Blast BENZALKONIUM CHLORIDE Rejoice International 5c109f7c-1f4d-484a-b6ea-3bbcf572bbac 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Hand Sanitizer Moisurize with Vitamin E and Aloe ETHYL ALCOHOL Rejoice International 2851ad2a-e108-424c-86d6-c898567695ef 2024-02-28 Warnings Exact identifier application number: M003 XtraCare Hand Sanitizer Moisturize with Vitamin E ETHYL ALCOHOL Rejoice International 13c99570-0859-4310-843a-5eb266698eb3 2024-02-28 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