AMERFRESH FLUORIDE .1 g/100g

Sodium Fluoride · PASTE, DENTIFRICE · Yangzhou ONE & ONLY Personal Care Products Co., LTD

No Recall HistoryCurrently in Shortage

Plain English

AMERFRESH FLUORIDE is a paste, dentifrice containing sodium fluoride at .1 g/100g, taken topical. Manufactured by Yangzhou ONE & ONLY Personal Care Products Co., LTD.

Key Facts

Brand Name: AMERFRESH FLUORIDE
Generic Name: Sodium Fluoride
NDC Code (Product): 85162-002
Manufacturer: Yangzhou ONE & ONLY Personal Care Products Co., LTD
Strength: .1 g/100g
Dosage Form: PASTE, DENTIFRICE
Route: TOPICAL
Marketing Status
Application #: M021
Marketing Start: 01/16/2025

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

Uses Aids in the prevention of dental cavities.

Dosage & Administration

Directions do not swallow supervise children as necessary until capable of useing without supervision instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing). Adults and children 6 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 a physician. Children under 6 years of age:do not use unless directed by a doctor or dentist.

Warnings

Warnings Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately. Keep out of reach of children.

Frequently Asked Questions

What is AMERFRESH FLUORIDE used for?

AMERFRESH FLUORIDE contains Sodium Fluoride. It is a paste, dentifrice taken topical. Consult your doctor for specific uses.

Is AMERFRESH FLUORIDE a controlled substance?

AMERFRESH FLUORIDE is not classified as a controlled substance by the DEA.

What is the generic name for AMERFRESH FLUORIDE?

The generic name for AMERFRESH FLUORIDE is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for AMERFRESH FLUORIDE .1 g/100g?

The NDC (National Drug Code) for AMERFRESH FLUORIDE .1 g/100g is 85162-002, listed by Yangzhou ONE & ONLY Personal Care Products Co., LTD.

Product NDC

85162-002

Package NDC

85162-002-01

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)