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Maximum Security
sodium fluoride · Maximum Security is an over-the-counter drug containing sodium fluoride, made by Bob Barker Company Inc..
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Dental
- Manufacturers
- 1
Helps protect against cavities.
Drug facts
- Generic name
- sodium fluoride
- Active ingredients
- Sodium Fluoride
- Dosage forms
- Gel, dentifrice
- Label holder
- Bob Barker Company Inc.
- FDA application
- M021
- Label updated
- 02/27/2024
Active ingredients
Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)
Purpose
Anticavity toothpaste
Uses
Helps protect against cavities.
Directions
Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years: Ask a dentist or physician.
Warnings
Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Keep out of reach of children
Under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Inactive ingredients
Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Sodium Hydroxide, Flavor, Sodium Saccharin, Sodium Benzoate, Disodium EDTA, Menthol
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Gel, dentifrice | 2.2 mg/g | dental | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 3,662 reports that list sodium fluoride, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Fatigue342
- Nausea313
- Pain286
- Diarrhea274
- Vomiting244
- Pneumonia235
- Pyrexia235
- Dizziness233
- Headache229
- Weight decreased225
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- Bob Barker Company Inc.Shown hereM021 · Label 02/27/2024 · NDC 53247-130Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIIDrugOngoing08/27/2025Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive...Haleon US Holdings LLC · Labeling: Label Mix-up: The outer carton is labelled Fresh Mint....
- Class IIDrug05/28/2025Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24...KENIL HEALTHCARE PRIVATE LIMITED · 11 products · CGMP Deviations
- Class IIDrugOngoing11/20/2024Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g)...Keystone Industries · Subpotent Drug
- Class IIIDrug09/18/2024Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for...Elevate Oral Care · LABELING: LABEL MIX-UP.
- Class IIDrug01/03/2024Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by...CARDINAL HEALTHCARE · CGMP Deviations: Products were exposed to temperatures outside of...
Maximum Security: common questions
- What is Maximum Security used for?
- Helps protect against cavities.
- Is Maximum Security a prescription drug?
- No. Maximum Security is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Maximum Security?
- Yes. Other FDA-listed products with the same active ingredients include Anticavity, Anticavity Fluoride Rinse, Alcohol-Free Anticavity, Anticavity Rinse.
- Who makes Maximum Security?
- Bob Barker Company Inc. lists Maximum Security with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 02/27/2024 · Label text is shown as published by the manufacturer. Not medical advice