Sodium Fluoride
.5 mg/mL · Solution/ Drops
- Prescription only
- Active substance
- Sodium Fluoride
- Made by
- Method Pharmaceuticals, LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-10-21
- As a supplemental source of Fluoride.
Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- As a supplemental source of Fluoride.
- It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries.1 Sodium Fluoride Drops were developed to provide systemic Fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water Fluoride level does not exceed 0.6 ppm F.
From the official label · 2025-10-21 · DailyMed
How it works
From this product’s own US prescribing label.
Sodium Fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization and by inhibiting the cariogenic microbial process.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-21
Do not take it if
Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.
Quoted from the official label, section “Contraindications”.
Other warnings
- Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm.
- Read directions carefully before using.
- Keep out of the reach of infants and children.
- See " Overdosage " section. Incompatibility of Fluoride with dairy foods has been reported due to formation of Calcium Fluoride which is poorly absorbed. Not for use in the eyes.
Quoted from the official label, section “Warnings”.
Side effects
- Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or Method Pharmaceuticals, LLC at 877-250-3427.
- Store at controlled room temperature 15° to 30°C (59° to 86°F).
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
50 mL bottles (58657-322-50)
Quoted from the official label, section “How Supplied”.
What is in it
- Each mL of Sodium Fluoride Drops contains 0.5 mg Fluoride ion (F) from 1.1 mg Sodium Fluoride (NaF).
- For use as a dental caries preventive in pediatric patients.
- Sugar Free, Alcohol Free, Dye Free and Gluten Free.
- Supplement Facts Serving Size:
- 1 mL Servings Per Container:
- 50 Amount per serving % Daily Value Fluoride (as Sodium Fluoride) 0.5 mg ** ** Daily Value not established.
- Active Ingredients: Sodium Fluoride (0.11% w/v).
- Other Ingredients:
- Glycerin, methylparaben, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.
- FLUORIDE SUPPLEMENT DOSAGE SCHEDULES AGE Fluoride Ion Level in Drinking Water (ppm)* < 0.3 ppm 0.3 - 0.6 ppm > 0.6 ppm Birth to 6 months None None None 6 months to 3 years Half dropperful 0.25 mg F (1/2 mL) None None 3 to 6 years One dropperful 0.5 mg F (1 mL)† Half dropperful 0.25 mg F (1/2 mL) None 6 to 16 years Two dropperfuls 1 mg F (2 mL) One dropperful 0.5 mg F (1 mL) None * 1.0 ppm = 1 mg/Liter † 1.1 mg Sodium Fluoride contains 0.5 mg Fluoride ion Fluoride Supplement Dose Schedule approved by the American Dental Association, American Academy of Pediatrics and American Academy of Pediatric Dentistry.
- KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (3)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 3 of 3
- Sodium FluorideThis onePrescription onlyMethod Pharmaceuticals, LLCNo ingredient list on the stored label
- Sensodyne Pronamel Intensive Enamel Repair Clean MintWithout prescriptionHaleon US Holdings LLCColour dyesSugar alcohols
- Sensodyne Pronamel Intensive Enamel Repair Extra FreshWithout prescriptionHaleon US Holdings LLCColour dyesSugar alcohols
Details
| Made by | Method Pharmaceuticals, LLC |
|---|---|
| Active substance | Sodium Fluoride |
| Strength | .5 mg/mL |
| Form | Solution/ Drops |
| Route | Oral |
| Packs | 50 mL in 1 BOTTLE, DROPPER |
| NDC | 58657-322 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.