warnings
Warnings for this product
Mouth 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
- Mouth Rinse
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Topco Associates LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- c640adc0-e178-4b6a-af44-07d2f7da81d3
- SPL ID
- 4ab7fbe5-4281-9c7d-e063-6394a90a2392
- Version
- 16
- Effective date
- 2026-02-13
- Source export date
- 2026-11-06
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 08:04:12
| 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 | Mouth Rinse | openfda.brand_name | |
| generic name | SODIUM FLUORIDE | openfda.generic_name | |
| manufacturer name | Topco Associates LLC | openfda.manufacturer_name | |
| ndc | package | 36800-001-86 | openfda.package_ndc |
| ndc | product | 36800-001 | openfda.product_ndc |
| ndc11 | package | 36800000186 | derived:openfda.package_ndc |
| rxcui | 1038904 | openfda.rxcui | |
| spl id | 4ab7fbe5-4281-9c7d-e063-6394a90a2392 | id | |
| spl set id | c640adc0-e178-4b6a-af44-07d2f7da81d3 | set_id | |
| unii | 8ZYQ1474W7 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTION DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 TOPCO VIJA0219 QUESTIONS? 1-888-423-0139 topcare@topco.com TOPCO VIJA1024 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com DSP-TN-21091 DSP-MO-20087 Scan her for more information or call 1-888-423-0139 QUALITY GUARANTEED
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.