NDC 50066-423

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 ID: 50066-423_7d7dd149-d648-3115-e053-2991aa0a02e4
• NDC: 50066-423
• Product Type: Human Otc Drug
• Proprietary Name: Nikzon Hemorrhoidal
• Generic Name: Phenylephrine Hydrochloride, And Pramoxine Hydrochloride
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-05-08
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: Genoma Lab USA Inc
• Substance Name: PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
• Active Ingredient Strength: 3 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50066-423-25

1 TUBE in 1 CARTON (50066-423-25) > 25 g in 1 TUBE

• Marketing Start Date: 2016-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50066-423-25 [50066042325]

Nikzon Hemorrhoidal CREAM

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-11-01

Drug Details

Active Ingredients

Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g

OpenFDA Data

• SPL SET ID: 062bf54b-e54b-4e9e-9ac1-f2f69f81f24a
• Manufacturer:
  • Genoma Lab USA Inc
• UNII:
  • 04JA59TNSJ
  • 88AYB867L5
• 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"

NDC	Brand Name	Generic Name
50066-423	Nikzon Hemorrhoidal	Phenylephrine Hydrochloride, and Pramoxine Hydrochloride
50066-001	Nikzon Hemorrhoidal	Nikzon Hemorrhoidal