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 91 of 114 · 2,277 matching rows.
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