Powder
- Product NDC
- 61354-117
- 11-digit product format
- 613540117
- Labeler code
- 61354
- Product ID
- 61354-117_3e1409fc-06d1-b3a9-e063-6294a90a06e3
- 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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1K09F3G675, 15FIX9V2JP |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61354-117-01 | Powder | 100 mg in 1 CUP | POWDER | 100 | | 3 |
| 61354-117-02 | 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 |
|---|
| 61354-117 | POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC] | 2 | Current NDC, 2 package rows | 20250508_08b52f29-c1a0-c673-e063-6294a90a9a7a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 61354-117-01 | 61354011701 | 100 mg in 1 CUP | 100 mg | | | | Historical |
| 61354-117-02 | 61354011702 | 1 CUP in 1 CARTON (61354-117-02) / 100 mg in 1 CUP (61354-117-01) | 1 cup | 2023-10-27 | No | No | Historical |