CloSYS
- Product NDC
- 58578-1234
- 11-digit product format
- 585781234
- Labeler code
- 58578
- Product ID
- 58578-1234_42ecdcc7-82b3-49f6-bff8-0b38c247433e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- RINSE
- Route
- ORAL
- Labeler
- Rowpar Pharmaceuticals, Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-02-18
- Substance
- SODIUM FLUORIDE
- Active strength
- .05 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CloSYS
- Brand name suffix
- Fluoride Rinse
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | .05 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 240698 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58578-1234-1 | CloSYSFluoride Rinse | 1 in 1 BOX | RINSE | 1 | | 8 |
| 58578-1234-1 | CloSYSFluoride Rinse | 473 mL in 1 BOTTLE | RINSE | 473 | | 8 |
| 58578-1234-2 | CloSYSFluoride Rinse | 100 mL in 1 BOTTLE | RINSE | 100 | | 8 |
| 58578-1234-2 | CloSYSFluoride Rinse | 100 mL in 1 BOTTLE | RINSE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58578-1234 | CLOSYS FLUORIDE RINSE (SODIUM FLUORIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241225_1a994f24-99ee-4b27-aab0-e816931a22c8.zip |
| 58578-1234 | CLOSYS FLUORIDE RINSE (SODIUM FLUORIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20160221_e164f877-3163-4c16-afae-ff83efb079d9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58578-1234-1 | 58578123401 | 1 BOTTLE in 1 BOX (58578-1234-1) > 473 mL in 1 BOTTLE | 1 bottle | 2016-02-18 | 0000-00-00 | No | No | Current |
| 58578-1234-2 | 58578123402 | 100 mL in 1 BOTTLE (58578-1234-2) | 100 ml | 2016-02-18 | 0000-00-00 | No | No | Current |