NDC 10237-750

Orajel for Cold Sores

Benzocaine

Orajel for Cold Sores is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzocaine; Petrolatum.

Product ID10237-750_5fb1d5b1-9752-3314-e053-2991aa0a2f86
NDC10237-750
Product TypeHuman Otc Drug
Proprietary NameOrajel for Cold Sores
Generic NameBenzocaine
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2010-07-27
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameChurch & Dwight Co., Inc.
Substance NameBENZOCAINE; PETROLATUM
Active Ingredient Strength200 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10237-750-21

1 TUBE in 1 CARTON (10237-750-21) > 5.9 g in 1 TUBE
Marketing Start Date2017-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-750-21 [10237075021]

Orajel for Cold Sores CREAM
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-27
Marketing End Date2019-12-31

NDC 10237-750-12 [10237075012]

Orajel for Cold Sores CREAM
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-07-27
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 mg/g

OpenFDA Data

SPL SET ID:9bb252f3-080b-4177-ab2e-10f7206c48ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1053368
  • 1053364
  • UPC Code
  • 0310310384012
  • NDC Crossover Matching brand name "Orajel for Cold Sores" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    10237-750Orajel for Cold SoresOrajel for Cold Sores
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE

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