NDC 10237-777

Benzocaine

Orajel Severe Toothache

Benzocaine is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzocaine; Menthol.

Product ID10237-777_8f011cd4-3331-09aa-e053-2a95a90a06b0
NDC10237-777
Product TypeHuman Otc Drug
Proprietary NameBenzocaine
Generic NameOrajel Severe Toothache
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2019-07-31
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameChurch & Dwight Co., Inc.
Substance NameBENZOCAINE; MENTHOL
Active Ingredient Strength200 g/mg; g/mg
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10237-777-45

1 BOTTLE, GLASS in 1 CARTON (10237-777-45) > 13.3 mg in 1 BOTTLE, GLASS
Marketing Start Date2019-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-777-45 [10237077745]

Benzocaine LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE200 g/mg

OpenFDA Data

SPL SET ID:8effae88-ec66-fe9b-e053-2995a90aef98
Manufacturer
UNII

NDC Crossover Matching brand name "Benzocaine" or generic name "Orajel Severe Toothache"

NDCBrand NameGeneric Name
67777-235BenzocaineBenzocaine
67777-246BenzocaineBenzocaine
71888-101BenzocaineBenzocaine
10237-767BenzocaineBenzocaine
10237-777BenzocaineBenzocaine
68599-9560BenzocaineBenzocaine
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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