warnings
Warnings
CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Rowpar Pharmaceuticals, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796
- SPL ID
- 5b621757-befa-4ce3-920d-b884aca94420
- Version
- 5
- Effective date
- 2026-04-01
- Source export date
- 2026-10-12
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:39:01
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M021 | openfda.application_number | |
| brand name | CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse | openfda.brand_name | |
| generic name | SODIUM FLUORIDE | openfda.generic_name | |
| manufacturer name | Rowpar Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 58578-0517-1 | openfda.package_ndc |
| ndc | package | 58578-0517-2 | openfda.package_ndc |
| ndc | package | 58578-0517-3 | openfda.package_ndc |
| ndc | package | 58578-0517-4 | openfda.package_ndc |
| ndc | product | 58578-0517 | openfda.product_ndc |
| ndc11 | package | 58578051701 | derived:openfda.package_ndc |
| ndc11 | package | 58578051704 | derived:openfda.package_ndc |
| ndc11 | package | 58578051703 | derived:openfda.package_ndc |
| ndc11 | package | 58578051702 | derived:openfda.package_ndc |
| rxcui | 313029 | openfda.rxcui | |
| spl id | 5b621757-befa-4ce3-920d-b884aca94420 | id | |
| spl set id | 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796 | set_id | |
| unii | 8ZYQ1474W7 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.