warnings
Warnings When using this product, do not swallow unless to do so by a dentist or physician. If more solution is accidentally swallowed than used for rinsing, get medical help or contact a Poison Control Center immediately.
ORTHO GUARD
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
- ORTHO GUARD
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Massco Dental A Division of Dunagin Pharmaceuticals
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd
- SPL ID
- 2a1d770f-d9a7-4980-a1f2-cf4df96d0f40
- Version
- 8
- Effective date
- 2023-12-17
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:21:00
| 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 | ORTHO GUARD | openfda.brand_name | |
| generic name | SODIUM FLUORIDE | openfda.generic_name | |
| manufacturer name | Massco Dental A Division of Dunagin Pharmaceuticals | openfda.manufacturer_name | |
| ndc | package | 63783-403-16 | openfda.package_ndc |
| ndc | package | 63783-401-16 | openfda.package_ndc |
| ndc | package | 63783-400-16 | openfda.package_ndc |
| ndc | product | 63783-403 | openfda.product_ndc |
| ndc | product | 63783-401 | openfda.product_ndc |
| ndc | product | 63783-400 | openfda.product_ndc |
| ndc11 | package | 63783040116 | derived:openfda.package_ndc |
| ndc11 | package | 63783040316 | derived:openfda.package_ndc |
| ndc11 | package | 63783040016 | derived:openfda.package_ndc |
| spl id | 2a1d770f-d9a7-4980-a1f2-cf4df96d0f40 | id | |
| spl set id | 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd | 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.