nivagen zinc oxide

Generic: zinc oxide

Labeler: nivagen pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nivagen zinc oxide
Generic Name zinc oxide
Labeler nivagen pharmaceuticals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

zinc oxide 200 mg/g

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-170
Product ID 75834-170_9b087880-cd9b-4a0e-be76-dcb0ad2fd11f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2018-05-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834170
Hyphenated Format 75834-170

Supplemental Identifiers

RxCUI
198911
UNII
SOI2LOH54Z

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 nivagen zinc oxide (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • 28.4 g in 1 TUBE (75834-170-01)
  • 56.7 g in 1 TUBE (75834-170-02)
  • 425 g in 1 JAR (75834-170-15)
source: ndc

Packages (3)

75834-170-01 28.4 g in 1 TUBE (75834-170-01) 75834-170-02 56.7 g in 1 TUBE (75834-170-02) 75834-170-15 425 g in 1 JAR (75834-170-15)

Ingredients (1)

zinc oxide (200 mg/g)

Linked Drug Pages (1)

NIVAGEN ZINC OXIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "9b087880-cd9b-4a0e-be76-dcb0ad2fd11f", "openfda": {"unii": ["SOI2LOH54Z"], "rxcui": ["198911"], "spl_set_id": ["7b42655b-2163-4637-9f5d-1d2efa1bdf1d"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 TUBE (75834-170-01)", "package_ndc": "75834-170-01", "marketing_start_date": "20180510"}, {"sample": false, "description": "56.7 g in 1 TUBE (75834-170-02)", "package_ndc": "75834-170-02", "marketing_start_date": "20180510"}, {"sample": false, "description": "425 g in 1 JAR (75834-170-15)", "package_ndc": "75834-170-15", "marketing_start_date": "20180510"}], "brand_name": "NIVAGEN ZINC OXIDE", "product_id": "75834-170_9b087880-cd9b-4a0e-be76-dcb0ad2fd11f", "dosage_form": "OINTMENT", "product_ndc": "75834-170", "generic_name": "zinc oxide", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NIVAGEN ZINC OXIDE", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "200 mg/g"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180510", "listing_expiration_date": "20261231"}