NDC 50066-001

Nikzon Hemorrhoidal

Phenylephrine Hydrochloride And Pramoxine Hydrochloride

Nikzon Hemorrhoidal is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Genoma Lab Usa Inc. The primary component is Phenylephrine Hydrochloride; Pramoxine Hydrochloride.

Product ID50066-001_1cccdc0f-9ede-4ab3-b984-c552720dfe0b
NDC50066-001
Product TypeHuman Otc Drug
Proprietary NameNikzon Hemorrhoidal
Generic NamePhenylephrine Hydrochloride And Pramoxine Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-12-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameGenoma Lab USA Inc
Substance NamePHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength3 mg/g; mg/g
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 50066-001-01

1 TUBE in 1 BOX (50066-001-01) > 25 g in 1 TUBE
Marketing Start Date2019-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50066-001-01 [50066000101]

Nikzon Hemorrhoidal CREAM
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-12-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

OpenFDA Data

SPL SET ID:e144fb04-db3c-4e22-9c9f-8378c7f0ce1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1293856
  • 1487925
  • UPC Code
  • 0650066000423
  • NDC Crossover Matching brand name "Nikzon Hemorrhoidal" or generic name "Phenylephrine Hydrochloride And Pramoxine Hydrochloride"

    NDCBrand NameGeneric Name
    50066-423Nikzon HemorrhoidalPhenylephrine Hydrochloride, and Pramoxine Hydrochloride
    50066-001NikzonPHENYLEPHRINE HYDROCHLORIDE and PRAMOXINE HYDROCHLORIDE

    Trademark Results [Nikzon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NIKZON
    NIKZON
    85896424 4507768 Live/Registered
    Genomma Lab Internacional, S.A.B. de C.V.
    2013-04-05
    NIKZON
    NIKZON
    77880350 not registered Dead/Abandoned
    Genomma Lab Internacional, S.A.B. de C.V.
    2009-11-24

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