warnings
WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
CloSYS
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
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Rowpar Pharmaceuticals, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- ed617c7a-805c-4788-9bce-9b7fead4312d
- SPL ID
- ea159a8d-4d2b-49ec-b6e6-f088312c0117
- Version
- 7
- Effective date
- 2026-03-31
- Source export date
- 2026-10-12
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:25:07
| 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 | openfda.brand_name | |
| generic name | SODIUM FLUORIDE | openfda.generic_name | |
| manufacturer name | Rowpar Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 58578-0759-3 | openfda.package_ndc |
| ndc | package | 58578-0759-2 | openfda.package_ndc |
| ndc | package | 58578-0759-1 | openfda.package_ndc |
| ndc | product | 58578-0759 | openfda.product_ndc |
| ndc11 | package | 58578075901 | derived:openfda.package_ndc |
| ndc11 | package | 58578075903 | derived:openfda.package_ndc |
| ndc11 | package | 58578075902 | derived:openfda.package_ndc |
| rxcui | 1099038 | openfda.rxcui | |
| spl id | ea159a8d-4d2b-49ec-b6e6-f088312c0117 | id | |
| spl set id | ed617c7a-805c-4788-9bce-9b7fead4312d | 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.