NDC 10237-704

Orajel Instant Pain Relief Regular Strength

Benzocaine

Orajel Instant Pain Relief Regular Strength is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Church & Dwight Co., Inc.. The primary component is Benzocaine.

Product ID10237-704_f0b25a23-829e-41c4-8cdc-58faaf3c243f
NDC10237-704
Product TypeHuman Otc Drug
Proprietary NameOrajel Instant Pain Relief Regular Strength
Generic NameBenzocaine
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2010-06-10
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameChurch & Dwight Co., Inc.
Substance NameBENZOCAINE
Active Ingredient Strength100 mg/g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 10237-704-25

1 TUBE in 1 CARTON (10237-704-25) > 7 g in 1 TUBE
Marketing Start Date2010-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10237-704-25 [10237070425]

Orajel Instant Pain Relief Regular Strength GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-06-10
Marketing End Date2019-12-31

NDC 10237-704-33 [10237070433]

Orajel Instant Pain Relief Regular Strength GEL
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-06-10
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE100 mg/g

OpenFDA Data

SPL SET ID:574c7911-e24b-4b52-b01f-df89d58fd505
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198488
  • 806606
  • UPC Code
  • 0310310222130
  • NDC Crossover Matching brand name "Orajel Instant Pain Relief Regular Strength" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    10237-704Orajel Instant Pain Relief Regular StrengthOrajel Instant Pain Relief Regular Strength
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.