warnings
Warnings Keep out of reach of children under 6 years of age. If more than used for rinsing is swallowed, get medical help or contact a Poison Control center right away. Do not swallow.
Ionite H
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
- Ionite H
- Generic name
- STANNOUS FLUORIDE
- Manufacturer
- Dharma Research, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 5c312b36-07f4-406e-b3d3-c6d1e964635d
- SPL ID
- 48ad63b9-3911-40fe-8bd2-bcace77e5713
- Version
- 2
- Effective date
- 2023-10-11
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:53:16
| Harmonized routes |
|---|
| DENTAL |
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 | Ionite H | openfda.brand_name | |
| generic name | STANNOUS FLUORIDE | openfda.generic_name | |
| manufacturer name | Dharma Research, Inc. | openfda.manufacturer_name | |
| ndc | package | 53045-275-10 | openfda.package_ndc |
| ndc | product | 53045-275 | openfda.product_ndc |
| ndc11 | package | 53045027510 | derived:openfda.package_ndc |
| rxcui | 583459 | openfda.rxcui | |
| spl id | 48ad63b9-3911-40fe-8bd2-bcace77e5713 | id | |
| spl set id | 5c312b36-07f4-406e-b3d3-c6d1e964635d | set_id | |
| unii | 3FTR44B32Q | 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.