Drugplain

biotene 1.4 mg/g

sodium monofluorophosphate · PASTE · Haleon US Holdings LLC

4 Recalls on RecordCurrently in Shortage
Plain English

biotene is a paste containing sodium monofluorophosphate at 1.4 mg/g, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
biotene
Generic Name
sodium monofluorophosphate
NDC Code (Product)
0135-0577
Manufacturer
Haleon US Holdings LLC
Strength
1.4 mg/g
Dosage Form
PASTE
Route
ORAL
Marketing Status
Application #
M022
Marketing Start
09/01/2016

Recall History

4 Recalls on Record
Class II07/15/2015

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

TerminatedVoluntary: Firm initiated
Class II07/15/2015

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

TerminatedVoluntary: Firm initiated
Class II07/15/2015

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

TerminatedVoluntary: Firm initiated
Class II07/15/2015

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is biotene used for?

biotene contains sodium monofluorophosphate. It is a paste taken oral. Consult your doctor for specific uses.

Is biotene a controlled substance?

biotene is not classified as a controlled substance by the DEA.

What is the generic name for biotene?

The generic name for biotene is sodium monofluorophosphate. There are 12 other brand versions of sodium monofluorophosphate.

What is the NDC code for biotene 1.4 mg/g?

The NDC (National Drug Code) for biotene 1.4 mg/g is 0135-0577, listed by Haleon US Holdings LLC.