NDC 54859-504

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 ID54859-504_3717669f-67e4-41b5-9700-40f421e25e61
NDC54859-504
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 54859-504-01

30 mL in 1 BOTTLE, SPRAY (54859-504-01)
Marketing Start Date2010-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-504-01 [54859050401]

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:7c50d986-6a7b-425f-90a0-a60e21283bdf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1485227
  • 1426687

    • 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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