powder

Generic: titanium dioxide

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

Drug Facts

Product Profile

Brand Name powder
Generic Name titanium dioxide
Labeler oxygen development llc
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

ferric oxide red 1.75 mg/100mg, titanium dioxide 10 mg/100mg

Manufacturer
Oxygen Development LLC

Identifiers & Regulatory

Product NDC 61354-117
Product ID 61354-117_3e1409fc-06d1-b3a9-e063-6294a90a06e3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M020
Listing Expiration 2026-12-31
Marketing Start 2023-10-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61354117
Hyphenated Format 61354-117

Supplemental Identifiers

UPC
0847137046743
UNII
1K09F3G675 15FIX9V2JP

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 powder (source: ndc)
Generic Name titanium dioxide (source: ndc)
Application Number M020 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.75 mg/100mg
  • 10 mg/100mg
source: ndc
Packaging
  • 1 CUP in 1 CARTON (61354-117-02) / 100 mg in 1 CUP (61354-117-01)
source: ndc

Packages (1)

61354-117-02 1 CUP in 1 CARTON (61354-117-02) / 100 mg in 1 CUP (61354-117-01)

Ingredients (2)

ferric oxide red (1.75 mg/100mg) titanium dioxide (10 mg/100mg)

Linked Drug Pages (1)

Powder ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3e1409fc-06d1-b3a9-e063-6294a90a06e3", "openfda": {"upc": ["0847137046743"], "unii": ["1K09F3G675", "15FIX9V2JP"], "spl_set_id": ["08b52f29-c1a0-c673-e063-6294a90a9a7a"], "manufacturer_name": ["Oxygen Development LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CUP in 1 CARTON (61354-117-02)  / 100 mg in 1 CUP (61354-117-01)", "package_ndc": "61354-117-02", "marketing_start_date": "20231027"}], "brand_name": "Powder", "product_id": "61354-117_3e1409fc-06d1-b3a9-e063-6294a90a06e3", "dosage_form": "POWDER", "product_ndc": "61354-117", "generic_name": "Titanium Dioxide", "labeler_name": "Oxygen Development LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Powder", "active_ingredients": [{"name": "FERRIC OXIDE RED", "strength": "1.75 mg/100mg"}, {"name": "TITANIUM DIOXIDE", "strength": "10 mg/100mg"}], "application_number": "M020", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231027", "listing_expiration_date": "20261231"}