SODIUM MONOFLUOROPHOSPHATE: 119 Adverse Event Reports & Safety Profile
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Route: DENTAL · Manufacturer: The Kroger Co. · FDA Application: 019518 · HUMAN OTC DRUG · FDA Label: Available
First Report: 2003 · Latest Report: 20250213
What Are the Most Common SODIUM MONOFLUOROPHOSPHATE Side Effects?
All SODIUM MONOFLUOROPHOSPHATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Oral discomfort | 11 | 9.2% | 0 | 0 |
| Dyspnoea | 10 | 8.4% | 1 | 2 |
| Hypersensitivity | 8 | 6.7% | 0 | 2 |
| Swollen tongue | 8 | 6.7% | 1 | 2 |
| Lip swelling | 7 | 5.9% | 0 | 0 |
| Stomatitis | 7 | 5.9% | 0 | 0 |
| Throat irritation | 7 | 5.9% | 0 | 0 |
| Toothache | 7 | 5.9% | 0 | 2 |
| Accidental exposure to product | 6 | 5.0% | 0 | 0 |
| Cough | 6 | 5.0% | 1 | 2 |
| Dysgeusia | 6 | 5.0% | 0 | 0 |
| Gingival pain | 6 | 5.0% | 0 | 1 |
| Oral pain | 6 | 5.0% | 0 | 1 |
| Vomiting | 6 | 5.0% | 1 | 1 |
| Dental caries | 5 | 4.2% | 0 | 1 |
| Faeces discoloured | 5 | 4.2% | 1 | 2 |
| Headache | 5 | 4.2% | 0 | 0 |
| Malaise | 5 | 4.2% | 0 | 2 |
| Tooth disorder | 5 | 4.2% | 0 | 0 |
Who Reports SODIUM MONOFLUOROPHOSPHATE Side Effects? Age & Gender Data
Gender: 56.8% female, 43.2% male. Average age: 53.4 years. Most reports from: US. View detailed demographics →
Is SODIUM MONOFLUOROPHOSPHATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2007 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2009 | 2 | 0 | 0 |
| 2011 | 1 | 0 | 1 |
| 2013 | 2 | 0 | 1 |
| 2014 | 10 | 0 | 1 |
| 2015 | 18 | 0 | 2 |
| 2016 | 6 | 0 | 1 |
| 2017 | 4 | 0 | 0 |
| 2018 | 7 | 0 | 1 |
| 2019 | 7 | 0 | 0 |
| 2020 | 3 | 1 | 1 |
| 2021 | 5 | 0 | 0 |
| 2022 | 6 | 0 | 1 |
| 2023 | 2 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
| 2025 | 2 | 0 | 0 |
What Is SODIUM MONOFLUOROPHOSPHATE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 31 |
| Dental disorder prophylaxis | 22 |
| Dental care | 10 |
| Dental cleaning | 6 |
| Dry mouth | 6 |
| Tooth discolouration | 6 |
SODIUM MONOFLUOROPHOSPHATE vs Alternatives: Which Is Safer?
Official FDA Label for SODIUM MONOFLUOROPHOSPHATE
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Dosage & Administration
Directions
- adults and children 2 years of age and older: o apply toothpaste onto a toothbrush o brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established.
- children under 2 years of age: Consult a dentist or doctor.
Warnings
WARNINGS ■ Fluorine content of this product is 977ppm. ■ In the following cases, immediately stop using this product and consult a doctor or dentist. (1) If you experience any abnormalities such as injury to your gums or the inside of your mouth while using this product. (2) If a child under 6 years old swallows a large amount. ■ Other precautions when using this product. (1) Be careful not to swallow it and rinse your mouth thoroughly after use. (2) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. ■ Precautions for storage. (1) Keep out of the reach of children under 6 years of age.
Active Ingredient
Active Ingredient Sodium Monofluorophosphate: 1.14% w/w (1,500 ppm fluoride as added) (0.15% w/w fluoride ion)
Inactive Ingredients
Inactive ingredients Sorbitol, Hydrated Silica, Water, Glycerin, Xylitol, Cellulose Gum, Sodium Lauroyl Sarcosinate, Sodium Cocoyl Glutamate, Tetrasodium Pyrophosphate, Rubas Idaeus Fruit Extract, Menthol, Mentha Pulegium Oil, Stevioside, Tocopheryl Acetate, Mentha Piperita Oil, Citrus Limon (Lemon)
Fruit
Oil, Sodium Bicarbonate, Centella Asiatica Extract, Curcuma Longa Root Extract, Melaleuca Alternifolia (Tea Tree)
Leaf
Oil, Eugenia Caryophyllus (Clove)
Flower
Oil, Clove Mint Flaovr, Cooling Flavor, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Gardenia Yellow Color, Gardenia Blue Color