Sodium Fluoride Gel
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
- Sodium Fluoride Gel
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- AvPAK
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- de973f9c-af34-4977-e053-2995a90a54a0
- SPL ID
- 47fc8e5e-ba96-0118-e063-6394a90ad45c
- Version
- 4
- Effective date
- 2026-01-09
- Source export date
- 2026-09-28
- Source partition
- 6
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:35:01
| 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 |
|---|---|---|---|
| brand name | Sodium Fluoride Gel | openfda.brand_name | |
| generic name | SODIUM FLUORIDE | openfda.generic_name | |
| manufacturer name | AvPAK | openfda.manufacturer_name | |
| ndc | package | 50268-733-56 | openfda.package_ndc |
| ndc | product | 50268-733 | openfda.product_ndc |
| ndc11 | package | 50268073356 | derived:openfda.package_ndc |
| spl id | 47fc8e5e-ba96-0118-e063-6394a90ad45c | id | |
| spl set id | de973f9c-af34-4977-e053-2995a90a54a0 | set_id | |
| unii | 8ZYQ1474W7 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel which could cause dental fluorosis. Read directions carefully before using. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. You should call your doctor, or dental professional for medical advice about serious adverse events. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.