NDC 61010-5300

Antiseptic

Benzalkonium Chloride, Benzocaine

Antiseptic is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Safetec Of America, Inc.. The primary component is Benzalkonium Chloride; Benzocaine.

Product ID61010-5300_3fa6dd25-1638-4464-870f-805dd81b4f61
NDC61010-5300
Product TypeHuman Otc Drug
Proprietary NameAntiseptic
Generic NameBenzalkonium Chloride, Benzocaine
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2012-02-15
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart333A
Labeler NameSafetec of America, Inc.
Substance NameBENZALKONIUM CHLORIDE; BENZOCAINE
Active Ingredient Strength1 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61010-5300-0

60 g in 1 BOTTLE, SPRAY (61010-5300-0)
Marketing Start Date2012-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61010-5300-0 [61010530000]

Antiseptic SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-15

NDC 61010-5300-2 [61010530002]

Antiseptic SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart333A
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-15

Drug Details

Active Ingredients

IngredientStrength
BENZALKONIUM CHLORIDE1 mg/g

OpenFDA Data

SPL SET ID:458e65f2-826d-4550-8c7d-17add2d7ba9a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1245229

    • NDC Crossover Matching brand name "Antiseptic" or generic name "Benzalkonium Chloride, Benzocaine"

    NDCBrand NameGeneric Name
    0363-7110Antisepticbenzalkonium chloride
    0498-0402AntisepticBenzalkonium chloride
    0869-0072AntisepticEucalyptol, Menthol, Methyl salicylate, thymol
    0869-0299AntisepticCETYLPYRIDINIUM CHLORIDE
    0924-7110Antisepticbenzalkonium chloride
    11673-299AntisepticCetylpyridinium chloride
    11673-318AntisepticEucalyptol, Menthol, Methyl Salicylate, Thymol
    33992-0072AntisepticEucalyptol, Menthol, Methyl salicylate, Thymol
    36800-299AntisepticCETYLPYRIDINIUM CHLORIDE
    37012-299AntisepticCetylpyridinium chloride
    68421-7120AntisepticAntiseptic
    68599-5322AntisepticAntiseptic
    71310-006AntisepticAntiseptic
    71622-001AntisepticAntiseptic
    75981-318AntisepticAntiseptic
    72663-111AntisepticAntiseptic
    75981-299AntisepticAntiseptic
    37205-664AntisepticAntiseptic
    37012-318AntisepticAntiseptic
    41250-072AntisepticAntiseptic
    41190-299AntisepticAntiseptic
    42507-299AntisepticAntiseptic
    42507-318AntisepticAntiseptic
    47682-306AntisepticAntiseptic
    47682-316AntisepticAntiseptic
    47682-245AntisepticAntiseptic
    47682-214AntisepticAntiseptic
    47682-302AntisepticAntiseptic
    47682-215AntisepticAntiseptic
    49035-299AntisepticAntiseptic
    49035-318AntisepticAntiseptic
    49348-482AntisepticAntiseptic
    49348-480AntisepticAntiseptic
    50804-299AntisepticAntiseptic
    50804-318AntisepticAntiseptic
    51143-210AntisepticAntiseptic
    51532-5300AntisepticAntiseptic
    51143-299AntisepticAntiseptic
    51532-5301AntisepticAntiseptic
    51718-3112AntisepticAntiseptic
    51718-3111AntisepticAntiseptic
    52116-7100AntisepticAntiseptic
    52124-0001AntisepticAntiseptic
    52641-700AntisepticAntiseptic
    55316-318AntisepticAntiseptic
    55301-318AntisepticAntiseptic
    55301-210AntisepticAntiseptic
    55301-299AntisepticAntiseptic
    55319-299AntisepticAntiseptic
    00904-7851Major Camphor and PhenolAntiseptic
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