Overview
Sodium fluoride is an inorganic chemical compound that is a source of the fluoride ion in many applications, including dental care and radiographic imaging when it is used as Fluoride ion F-18. Sodium fluoride's benefits on dental health were first observed in the 1930s, when individuals in communities with fluoridated drinking water showed less tooth decay than those without fluoridated water. The use of fluoride in dental practice began in the 1940s. Now, sodium fluoride may be found in a variety of gels, varnishes, rinses, toothpaste products, and fluoride treatments provided in dental care. According to the American Dental Association (ADA), thorough evidence reviews have indicated that the use of fluoride to prevent and control dental caries is safe when used correctly and is highly effective in reducing the prevalence of caries.
Indication
Sodium fluoride in the oral or topical form is indicated for the prevention and control of dental caries and for the maintenance of dental health. Fluoride supplements in the form of tablets and other formulas may be prescribed to prevent tooth decay in high-risk children aged 6 months to 16 years old whose drinking water source contains low fluoride concentrations.
Associated Conditions
- Cavity
- Dental Cavity
- Dental Decay
- Dental Health
- Enamel Caries
- Partial Denture Wearers Wear of the Natural Enamel
- Sensitivity, Tooth
- Trace Element Deficiency
- Wear of the Natural Enamel caused by teeth grinding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/18 | Phase 1 | Completed | |||
2023/12/26 | Phase 1 | Completed | |||
2023/12/18 | Phase 2 | Not yet recruiting | Sun Yat-sen University | ||
2020/01/30 | Phase 3 | Completed | |||
2019/10/14 | Not Applicable | Completed | Kırıkkale University | ||
2019/04/24 | Phase 4 | UNKNOWN | |||
2018/08/10 | Not Applicable | Completed | Merve Erkmen Almaz | ||
2017/08/03 | Phase 2 | Completed | |||
2017/03/24 | Early Phase 1 | Withdrawn | |||
2015/12/01 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Young Dental Manufacturing Co 1, LLC | 0273-0392 | DENTAL | 2.72 g in 100 g | 12/14/2018 | |
| Colgate Oral Pharmaceuticals, Inc. | 0126-0072 | DENTAL | 6 mg in 1 mL | 6/1/2023 | |
| Ross Healthcare Inc. | 62007-054 | topical | .02 mg in 1 mL | 2/3/2015 | |
| Dharma Research, Inc. | 53045-228 | DENTAL | 10.241 g in 100 g | 7/2/2021 | |
| Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | 0699-0153 | DENTAL | 27.3 mg in 1 g | 1/26/2024 | |
| M&S Dental Supply Co., LLC | 69745-014 | DENTAL | 5.6 g in 454 g | 1/27/2022 | |
| Ross Healthcare Inc. | 62007-006 | topical | 27.2 mg in 1 mg | 5/29/2014 | |
| CarWin Pharmaceutical Associates, LLC | 15370-105 | ORAL | 1 mg in 1 1 | 1/10/2024 | |
| Pascal Company, Inc. | 10866-0093 | TOPICAL, BUCCAL, DENTAL | 9.05 mg in 1 g | 3/26/2015 | |
| Darby Dental Supply, LLC | 66467-2250 | DENTAL | 5.6 g in 454 g | 1/24/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DURAPHAT 50mg/ml DENTAL SUSPENSION | SIN07802P | LIQUID | 50 mg/ml | 7/21/1994 | |
| Nutritrace Concentrate for solution for infusion | SIN14341P | INFUSION, SOLUTION CONCENTRATE | 1.260mg/10ml | 4/22/2013 | |
| PEDITRACE CONCENTRATE FOR PARENTERAL INFUSION | SIN08899P | INJECTION | 126 mcg/ml | 9/4/1996 | |
| ADDAVEN CONCENTRATE FOR SOLUTION FOR INFUSION | SIN15302P | INFUSION, SOLUTION CONCENTRATE | 210 mcg/ml | 7/24/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sodium Fluoride and Glycerol Paste | 国药准字H42022317 | 化学药品 | 糊剂 | 6/15/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CHLOROFLUOR GEL bottle | 21505 | Medicine | A | 10/8/1991 | |
| NEUTRAFLUOR 5000 SENSITIVE TOOTHPASTE bottle | 176745 | Medicine | A | 10/18/2010 | |
| LISTERINE TEETH DEFENCE ANTISEPTIC MOUTHWASH bottle (reformulation) | 201303 | Medicine | A | 9/25/2012 | |
| PERIO PACK | 91660 | Medicine | A | 11/5/2002 | |
| LACLEDE FLUORIDE FOAM (total fluoride ion 1.23%) tyranna grape flavour aerosol bottle | 73427 | Medicine | A | 6/1/2000 | |
| LACLEDE FLUORIDE FOAM (total fluoride ion 1.23%) koala berry flavour aerosol bottle | 73428 | Medicine | A | 6/1/2000 | |
| Colgate Sensitive Advanced Clean Fluoride Toothpaste | 310283 | Medicine | A | 10/11/2018 | |
| FLUOROCARE 200 DAILY FLUORIDE MOUTH RINSE COOL MINT bottle | 78339 | Medicine | A | 5/3/2001 | |
| Sensodyne Daily Care | 489705 | Medicine | A | 5/23/2025 | |
| RADPHARM LEUCOCYTE LABELLING KIT injection composite pack | 14333 | Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific | Medicine | A | 9/5/1991 |
Help Us Improve
Your feedback helps us provide better drug information and insights.