Home NDC 61354-189 Powder
Product NDC 61354-189
11-digit product format 613540189
Labeler code 61354
Product ID 61354-189_4d39fb2d-8fa3-07c9-e063-6394a90a0d4e
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 2025-07-25
Substance TITANIUM DIOXIDE
Active strength 10 mg/100mg
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 10 mg/100mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 61354-189-01 Powder 1 in 1 CARTON POWDER 1 1 61354-189-01 Powder 100 mg in 1 CUP POWDER 100 1
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 61354-189-01 61354018901 1 CUP in 1 CARTON (61354-189-01) / 100 mg in 1 CUP 1 cup 2025-07-25 No No Current