NDC 58578-0749-01 - CloSYS
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 58578-0749
- Requested NDC
- 58578-0749-01
- Package NDCs from labels
- 58578-0749-1, 58578-0749-2, 58578-0749-3, 58578-0749-4, 58578-0749-01
- Manufacturer
- Rowpar Pharmaceuticals, Inc.
- Effective date
- 2026-03-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| CloSYS Fluoride Toothpaste | Rowpar Pharmaceuticals, Inc. | 2026-03-31 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58578-0749-1 | CloSYS | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 11 | |
| 58578-0749-1 | CloSYS | 96 g in 1 TUBE | PASTE, DENTIFRICE | 96 | 11 | |
| 58578-0749-2 | CloSYS | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 11 | |
| 58578-0749-2 | CloSYS | 198 g in 1 TUBE | PASTE, DENTIFRICE | 198 | 11 | |
| 58578-0749-3 | CloSYS | 21 g in 1 TUBE | PASTE, DENTIFRICE | 21 | 11 | |
| 58578-0749-3 | CloSYS | 1 in 1 BOX | PASTE, DENTIFRICE | 1 | 11 | |
| 58578-0749-4 | CloSYS | 198 g in 1 TUBE | PASTE, DENTIFRICE | 198 | 11 | |
| 58578-0749-4 | CloSYS | 2 in 1 PACKAGE | PASTE, DENTIFRICE | 2 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58578-0749 | CLOSYS (SODIUM FLUORIDE) PASTE, DENTIFRICE [ROWPAR PHARMACEUTICALS, INC.] | 10 | Current NDC, Legacy NDC, 8 package rows | 20250523_5f87abb7-0e9d-6369-e053-2a91aa0a2411.zip |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.