NDC 54859-503

Orasep

Benzocaine, Menthol, Cetylpyridinium Chloride

Orasep is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is Benzocaine; Menthol; Cetylpyridinium Chloride.

Product ID54859-503_0d736755-babb-4ec8-8a9a-c92010578881
NDC54859-503
Product TypeHuman Otc Drug
Proprietary NameOrasep
Generic NameBenzocaine, Menthol, Cetylpyridinium Chloride
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2010-04-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameLlorens Pharmaceutical International Division
Substance NameBENZOCAINE; MENTHOL; CETYLPYRIDINIUM CHLORIDE
Active Ingredient Strength2 mg/100mL; mg/100mL; mg/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54859-503-01

30 mL in 1 BOTTLE (54859-503-01)
Marketing Start Date2010-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-503-01 [54859050301]

Orasep LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2010-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
BENZOCAINE2 mg/100mL

OpenFDA Data

SPL SET ID:ed70911b-9da8-4e1d-97fa-66b18d28516a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1547767
  • 1362704
  • NDC Crossover Matching brand name "Orasep" or generic name "Benzocaine, Menthol, Cetylpyridinium Chloride"

    NDCBrand NameGeneric Name
    54859-503OrasepBenzocaine, Menthol, Cetylpyridinium Chloride
    54859-504OrasepBenzocaine, Menthol, Cetylpyridinium Chloride
    63102-106ACTISEPBENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE
    63102-107ACTISEPBENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE

    Trademark Results [Orasep]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORASEP
    ORASEP
    87837446 5586007 Live/Registered
    LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.
    2018-03-16

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