Classic Mint Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g

Sodium Fluoride · GEL · HISMILE PTY LTD

No Recall HistoryCurrently in Shortage

Plain English

This is a topical fluoride toothpaste gel that helps prevent tooth decay and cavities when used as directed for oral hygiene. It is available over-the-counter and comes in a classic mint flavor.

Key Facts

Brand Name: Classic Mint Flavor Sodium Fluoride Anticavity Toothpast
Generic Name: Sodium Fluoride
NDC Code (Product): 83013-340
Manufacturer: HISMILE PTY LTD
Strength: .243 g/100g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Application #: M021
Marketing Start: 10/30/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports

fatigue159 reports

nausea158 reports

vomiting156 reports

pain154 reports

weight increased154 reports

nasopharyngitis152 reports

type 2 diabetes mellitus145 reports

peripheral swelling144 reports

urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use Aids in the prevention of dental cavities.

Dosage & Administration

Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use 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.

Warnings

Warnings Warnings When using this product Do not swallow Do not use in eye area Keep out of reach of children under 6 years If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Classic Mint Flavor Sodium Fluoride Anticavity Toothpast used for?

This is a topical fluoride toothpaste gel that helps prevent tooth decay and cavities when used as directed for oral hygiene. It is available over-the-counter and comes in a classic mint flavor.

Is Classic Mint Flavor Sodium Fluoride Anticavity Toothpast a controlled substance?

Classic Mint Flavor Sodium Fluoride Anticavity Toothpast is not classified as a controlled substance by the DEA.

What is the generic name for Classic Mint Flavor Sodium Fluoride Anticavity Toothpast?

The generic name for Classic Mint Flavor Sodium Fluoride Anticavity Toothpast is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for Classic Mint Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g?

The NDC (National Drug Code) for Classic Mint Flavor Sodium Fluoride Anticavity Toothpast .243 g/100g is 83013-340, listed by HISMILE PTY LTD.

Product NDC

83013-340

Package NDC

83013-340-10

Other Sodium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)