nikzon hemorrhoidal

Generic: glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride

Labeler: genomma lab usa
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nikzon hemorrhoidal
Generic Name glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride
Labeler genomma lab usa
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

glycerin 144 mg/g, petrolatum 150 mg/g, phenylephrine hydrochloride 2.5 mg/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Genomma Lab USA

Identifiers & Regulatory

Product NDC 50066-010
Product ID 50066-010_6be21f1f-a1cc-40cc-82ab-a663264c640c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M015
Listing Expiration 2026-12-31
Marketing Start 2025-07-07

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50066010
Hyphenated Format 50066-010

Supplemental Identifiers

RxCUI
1293649
UNII
PDC6A3C0OX 4T6H12BN9U 04JA59TNSJ 88AYB867L5
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nikzon hemorrhoidal (source: ndc)
Generic Name glycerin, petrolatum, phenylephrine hydrochloride, and pramoxine hydrochloride (source: ndc)
Application Number M015 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 144 mg/g
  • 150 mg/g
  • 2.5 mg/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (50066-010-09) / 25.5 g in 1 TUBE
source: ndc

Packages (1)

50066-010-09 1 TUBE in 1 CARTON (50066-010-09) / 25.5 g in 1 TUBE

Ingredients (4)

glycerin (144 mg/g) petrolatum (150 mg/g) phenylephrine hydrochloride (2.5 mg/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Nikzon Hemorrhoidal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "6be21f1f-a1cc-40cc-82ab-a663264c640c", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "unii": ["PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5"], "rxcui": ["1293649"], "spl_set_id": ["8f9a9939-2c99-489f-b597-9a51ec2684f9"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Genomma Lab USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (50066-010-09)  / 25.5 g in 1 TUBE", "package_ndc": "50066-010-09", "marketing_start_date": "20250707"}], "brand_name": "Nikzon Hemorrhoidal", "product_id": "50066-010_6be21f1f-a1cc-40cc-82ab-a663264c640c", "dosage_form": "CREAM", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "50066-010", "generic_name": "Glycerin, Petrolatum, Phenylephrine hydrochloride, and Pramoxine hydrochloride", "labeler_name": "Genomma Lab USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nikzon Hemorrhoidal", "active_ingredients": [{"name": "GLYCERIN", "strength": "144 mg/g"}, {"name": "PETROLATUM", "strength": "150 mg/g"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M015", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250707", "listing_expiration_date": "20261231"}