NDC 72337-776

Orajel

Benzocaine

Orajel is a Dental Strip in the Human Otc Drug category. It is labeled and distributed by Biofilm. The primary component is Menthol; Benzocaine.

Product ID72337-776_79a1323c-1dcd-0f99-e053-2a91aa0afe20
NDC72337-776
Product TypeHuman Otc Drug
Proprietary NameOrajel
Generic NameBenzocaine
Dosage FormStrip
Route of AdministrationDENTAL
Marketing Start Date2018-11-05
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameBioFilm
Substance NameMENTHOL; BENZOCAINE
Active Ingredient Strength25 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 72337-776-01

1 PACKAGE in 1 CARTON (72337-776-01) > 8 g in 1 PACKAGE
Marketing Start Date2019-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72337-776-01 [72337077601]

Orajel STRIP
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-15

Drug Details

Active Ingredients

IngredientStrength
MENTHOL25 mg/g

OpenFDA Data

SPL SET ID:71d7e8b7-a059-7843-e053-2a95a90affde
Manufacturer
UNII
UPC Code
  • 0310310998868
  • NDC Crossover Matching brand name "Orajel" or generic name "Benzocaine"

    NDCBrand NameGeneric Name
    72337-776OrajelOrajel
    10237-775OrajelOrajel
    0283-0220HurriCaineBenzocaine
    0283-0293HurriCaineBenzocaine
    0283-0520HurriCaineBenzocaine
    0283-0569HurriCaineBenzocaine
    0283-0679HurriCaineBenzocaine
    0283-0871HurriCaineBENZOCAINE
    0283-0886HurriCaineBenzocaine
    0283-0914HurriCaineBenzocaine
    0283-0920HurriCaineBenzocaine
    0283-0998HurriCaineBenzocaine
    0283-1016HurriCaineBENZOCAINE

    Trademark Results [Orajel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORAJEL
    ORAJEL
    88721637 not registered Live/Pending
    CHURCH & DWIGHT CO., INC.
    2019-12-10
    ORAJEL
    ORAJEL
    85639740 4277337 Dead/Cancelled
    Church & Dwight Co., Inc.
    2012-05-31
    ORAJEL
    ORAJEL
    85639732 4277336 Dead/Cancelled
    Church & Dwight Co., Inc.
    2012-05-31
    ORAJEL
    ORAJEL
    85135337 3950958 Live/Registered
    Church & Dwight Co., Inc.
    2010-09-22
    ORAJEL
    ORAJEL
    77653394 3647531 Live/Registered
    CHURCH & DWIGHT CO., INC.
    2009-01-21
    ORAJEL
    ORAJEL
    77648363 3647521 Live/Registered
    CHURCH & DWIGHT CO., INC.
    2009-01-13
    ORAJEL
    ORAJEL
    73277429 1166935 Live/Registered
    COMMERCE DRUG CO., INC.
    1980-09-09

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