covered

Generic: zinc oxide

Labeler: potency no. 710 llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name covered
Generic Name zinc oxide
Labeler potency no. 710 llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide 200 mg/g

Manufacturer
Potency No. 710 LLC

Identifiers & Regulatory

Product NDC 85319-205
Product ID 85319-205_459bf744-e43a-54c3-e063-6294a90a1afd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2019-06-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85319205
Hyphenated Format 85319-205

Supplemental Identifiers

UNII
SOI2LOH54Z

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 covered (source: ndc)
Generic Name zinc oxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/g
source: ndc
Packaging
  • 113 g in 1 BOTTLE, PUMP (85319-205-04)
source: ndc

Packages (1)

85319-205-04 113 g in 1 BOTTLE, PUMP (85319-205-04)

Ingredients (1)

zinc oxide (200 mg/g)

Linked Drug Pages (2)

COVERED ndc-match (0.9) COVERED ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "459bf744-e43a-54c3-e063-6294a90a1afd", "openfda": {"unii": ["SOI2LOH54Z"], "spl_set_id": ["3117faeb-1792-1b2e-e063-6294a90a92df"], "manufacturer_name": ["Potency No. 710 LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 BOTTLE, PUMP (85319-205-04)", "package_ndc": "85319-205-04", "marketing_start_date": "20190628"}], "brand_name": "COVERED", "product_id": "85319-205_459bf744-e43a-54c3-e063-6294a90a1afd", "dosage_form": "CREAM", "product_ndc": "85319-205", "generic_name": "Zinc Oxide", "labeler_name": "Potency No. 710 LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COVERED", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "200 mg/g"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190628", "listing_expiration_date": "20261231"}