Drugplain

Sodium Monofluorophosphate 760 mg/g

White Toothpaste · PASTE · Dynarex Corporation

8 Recalls on Record
Plain English

Sodium Monofluorophosphate is a paste containing white toothpaste at 760 mg/g, taken dental. Manufactured by Dynarex Corporation.

Key Facts

Brand Name
Sodium Monofluorophosphate
Generic Name
White Toothpaste
NDC Code (Product)
67777-181
Manufacturer
Dynarex Corporation
Strength
760 mg/g
Dosage Form
PASTE
Route
DENTAL
Marketing Status
Application #
M021
Marketing Start
07/16/2024

Recall History

8 Recalls on Record
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class III06/06/2014

Estee Lauder Inc

Stability Data Does Not Support Expiry

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II09/17/2018

Medline Industries Inc

Microbial Contamination of Non-Sterile Product

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective2 reports
pelvic fracture2 reports
abdominal discomfort1 reports
abdominal pain upper1 reports
bone metabolism disorder1 reports
burning sensation1 reports
cardiac disorder1 reports
chest pain1 reports
condition aggravated1 reports
confusional state1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) Helps protect against cavities

Dosage & Administration

Directions • Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. • Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established. • Children under 2 years: Ask a dentist or physician.

Warnings

Warnings If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediatley. Keep out of reach of children Keep out of reach of childen under 6 years of age

Frequently Asked Questions

What is Sodium Monofluorophosphate used for?

Sodium Monofluorophosphate contains White Toothpaste. It is a paste taken dental. Consult your doctor for specific uses.

Is Sodium Monofluorophosphate a controlled substance?

Sodium Monofluorophosphate is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Monofluorophosphate?

The generic name for Sodium Monofluorophosphate is White Toothpaste. There are no other listed brand versions of White Toothpaste.

What is the NDC code for Sodium Monofluorophosphate 760 mg/g?

The NDC (National Drug Code) for Sodium Monofluorophosphate 760 mg/g is 67777-181, listed by Dynarex Corporation.

Product NDC

67777-181

Package NDC

67777-181-02

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

Data from openFDA · Public domain (CC0 1.0)