cream

Generic: zinc oxide

Labeler: monat global corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cream
Generic Name zinc oxide
Labeler monat global corp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide 18.8 mg/100mg

Manufacturer
MONAT GLOBAL CORP

Identifiers & Regulatory

Product NDC 78518-007
Product ID 78518-007_46e05ccb-82a8-f692-e063-6294a90a079a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2022-09-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78518007
Hyphenated Format 78518-007

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 18.8 mg/100mg
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (78518-007-01) / 35 mg in 1 TUBE
source: ndc

Packages (1)

78518-007-01 1 TUBE in 1 CARTON (78518-007-01) / 35 mg in 1 TUBE

Ingredients (1)

zinc oxide (18.8 mg/100mg)

Linked Drug Pages (1)

Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "46e05ccb-82a8-f692-e063-6294a90a079a", "openfda": {"unii": ["SOI2LOH54Z"], "spl_set_id": ["e9231470-9292-0e70-e053-2a95a90a767a"], "manufacturer_name": ["MONAT GLOBAL CORP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (78518-007-01)  / 35 mg in 1 TUBE", "package_ndc": "78518-007-01", "marketing_start_date": "20220912"}], "brand_name": "Cream", "product_id": "78518-007_46e05ccb-82a8-f692-e063-6294a90a079a", "dosage_form": "CREAM", "product_ndc": "78518-007", "generic_name": "ZINC OXIDE", "labeler_name": "MONAT GLOBAL CORP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cream", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "18.8 mg/100mg"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220912", "listing_expiration_date": "20261231"}