cream

Generic: zinc oxide

Labeler: oxygen development llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cream
Generic Name zinc oxide
Labeler oxygen development llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

zinc oxide 21.76 mg/100mg

Manufacturer
Oxygen Development LLC

Identifiers & Regulatory

Product NDC 61354-115
Product ID 61354-115_08a1e862-b55b-fb84-e063-6294a90a016a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2023-10-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61354115
Hyphenated Format 61354-115

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
  • 21.76 mg/100mg
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01)
source: ndc

Packages (1)

61354-115-02 1 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01)

Ingredients (1)

zinc oxide (21.76 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": "08a1e862-b55b-fb84-e063-6294a90a016a", "openfda": {"unii": ["SOI2LOH54Z"], "spl_set_id": ["08a1e862-b55a-fb84-e063-6294a90a016a"], "manufacturer_name": ["Oxygen Development LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (61354-115-02)  / 100 mg in 1 TUBE (61354-115-01)", "package_ndc": "61354-115-02", "marketing_start_date": "20231026"}], "brand_name": "Cream", "product_id": "61354-115_08a1e862-b55b-fb84-e063-6294a90a016a", "dosage_form": "CREAM", "product_ndc": "61354-115", "generic_name": "Zinc Oxide", "labeler_name": "Oxygen Development LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cream", "active_ingredients": [{"name": "ZINC OXIDE", "strength": "21.76 mg/100mg"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231026", "listing_expiration_date": "20261231"}