NDC 67659-150

Orajel for Cold Sores Single Dose

Benzalkonium Chloride, Benzocaine

Orajel for Cold Sores Single Dose is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Team Technologies, Inc. The primary component is Benzalkonium Chloride; Benzocaine.

Product ID67659-150_82341662-e7c6-9c81-e053-2991aa0a49c0
NDC67659-150
Product TypeHuman Otc Drug
Proprietary NameOrajel for Cold Sores Single Dose
Generic NameBenzalkonium Chloride, Benzocaine
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2012-07-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameTeam Technologies, Inc
Substance NameBENZALKONIUM CHLORIDE; BENZOCAINE
Active Ingredient Strength0 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67659-150-25

.08 g in 1 VIAL, SINGLE-DOSE (67659-150-25)
Marketing Start Date2016-09-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67659-150-25 [67659015025]

Orajel for Cold Sores Single Dose LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-09

Drug Details

Active Ingredients

IngredientStrength
BENZALKONIUM CHLORIDE.13 mg/g

OpenFDA Data

SPL SET ID:3c13e246-9175-7314-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1301152
  • 1301158

    • NDC Crossover Matching brand name "Orajel for Cold Sores Single Dose" or generic name "Benzalkonium Chloride, Benzocaine"

    NDCBrand NameGeneric Name
    51532-5300Antisepticbenzalkonium chloride, benzocaine
    51532-5301Antisepticbenzalkonium chloride, benzocaine
    61010-5300Antisepticbenzalkonium chloride, benzocaine
    69103-5300Antisepticbenzalkonium chloride, benzocaine
    73598-0681Antisepticbenzalkonium chloride, benzocaine
    81238-5300aramark AntisepticBENZALKONIUM CHLORIDE, BENZOCAINE
    51532-4616CUT CLEANERBENZALKONIUM CHLORIDE, BENZOCAINE
    81238-4616CUT CLEANERBENZALKONIUM CHLORIDE, BENZOCAINE
    50332-0212First AidBenzalkonium Chloride, Benzocaine
    62985-5081First Aid Antisepticbenzalkonium chloride, benzocaine
    0498-0015North First Aid AntisepticBenzalkonium Chloride, Benzocaine
    10237-798Orajel Cold Sore Touch Free - Single DoseBenzalkonium Chloride, Benzocaine
    10237-741Orajel for Cold SoresBenzalkonium Chloride, Benzocaine
    10237-756Orajel for Cold SoresBenzalkonium Chloride, Benzocaine
    67659-150Orajel for Cold SoresBenzalkonium Chloride, Benzocaine
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