OMNI
- Product NDC
- 48878-4061
- 11-digit product format
- 488784061
- Labeler code
- 48878
- Product ID
- 48878-4061_5f88065a-e74d-4285-93d2-b208bf197523
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Stannous Fluoride
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Solventum US LLC
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-02-01
- Substance
- STANNOUS FLUORIDE
- Active strength
- .969 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OMNI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| STANNOUS FLUORIDE | .969 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3FTR44B32Q |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48878-4061-3 | OMNI | 1 in 1 BOX | GEL | 1 | | 7 |
| 48878-4061-3 | OMNI | 121.9 g in 1 TUBE | GEL | 121.9 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 48878-4061 | OMNI (STANNOUS FLUORIDE) GEL [SOLVENTUM US LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240808_0c2a81b1-65b5-432b-8e66-30432a245aba.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 48878-4061-3 | 48878406103 | 1 TUBE in 1 BOX (48878-4061-3) / 121.9 g in 1 TUBE | 1 tube | 1998-02-01 | 0000-00-00 | No | No | Current |