Home NDC 61354-119 Powder
Product NDC 61354-119
11-digit product format 613540119
Labeler code 61354
Product ID 61354-119_3e142cd6-160d-62f8-e063-6394a90ae70c
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide
Dosage form POWDER
Route TOPICAL
Labeler Oxygen Development LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-27
Substance FERRIC OXIDE RED; TITANIUM DIOXIDE
Active strength 1.75; 10 mg/100mg; mg/100mg
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Powder
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 1.75 mg/100mg TITANIUM DIOXIDE 10 mg/100mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup 15FIX9V2JP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61354-119-01 Powder 100 mg in 1 CUP POWDER 100 3 61354-119-02 Powder 1 in 1 CARTON POWDER 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61354-119 POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC] 2 Current NDC, 2 package rows 20250508_08b8003f-40be-3380-e063-6294a90a4f6b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 61354-119-01 61354011901 100 mg in 1 CUP 100 mg Historical 61354-119-02 61354011902 1 CUP in 1 CARTON (61354-119-02) / 100 mg in 1 CUP (61354-119-01) 1 cup 2023-10-27 No No Current