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
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 4d39ed7a-ca80-893c-e063-6294a90a03e7 | 2026-03-17 | Warnings | Exact identifier |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings For external use only
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 15FIX9V2JP |
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 |
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 |