Drugplain

Mouth Rinse .1 mg/mL

sodium fluoride · MOUTHWASH · Topco Associates LLC

4 Recalls on RecordCurrently in Shortage
Plain English

Sodium fluoride mouthwash is an over-the-counter oral rinse used to help prevent tooth decay and strengthen tooth enamel. It contains fluoride at a concentration of 0.1 mg/mL and is swished around in the mouth as directed on the product label.

Key Facts

Brand Name
Mouth Rinse
Generic Name
sodium fluoride
NDC Code (Product)
36800-001
Manufacturer
Topco Associates LLC
Strength
.1 mg/mL
Dosage Form
MOUTHWASH
Route
ORAL
Marketing Status
Application #
M021
Marketing Start
12/30/2010

Recall History

4 Recalls on Record
Class III07/18/2013

Vi-Jon, Inc.

Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.

TerminatedVoluntary: Firm initiated
Class III09/05/2023

Vi-Jon, LLC

Incorrect/Undeclared Excipients.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II04/06/2020

The Medicine Shoppe Pharmacy

Lack of Processing Control

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective709 reports
macular degeneration589 reports
pain553 reports
nausea480 reports
pyrexia471 reports
off label use460 reports
constipation458 reports
weight decreased407 reports
headache347 reports
infusion related reaction318 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps control plaque that leads to gingivitis

Dosage & Administration

Directions adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow children under 12 years of age - consult a dentist or doctor this rinse is not intended to replace brushing or flossing

Warnings

Warnings for this product

Adverse Reactions

Adverse reaction *This product is manufactued or distributed by Kenvue, Inc., distributor of Original Listerine ® Antiseptic Mouthwash. DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99 PLEASANTON, CA 94566-0009 ‡1-888-723-3929 LOVE IT OR IT'S ON US‡ Scan here for more information Empty & Replace Cap PLASTIC BOTTLE how2recycle.info DSP-TN-210091 DSP-MO-20087

Frequently Asked Questions

What is Mouth Rinse used for?

Sodium fluoride mouthwash is an over-the-counter oral rinse used to help prevent tooth decay and strengthen tooth enamel. It contains fluoride at a concentration of 0.1 mg/mL and is swished around in the mouth as directed on the product label.

Is Mouth Rinse a controlled substance?

Mouth Rinse is not classified as a controlled substance by the DEA.

What is the generic name for Mouth Rinse?

The generic name for Mouth Rinse is sodium fluoride. There are 12 other brand versions of sodium fluoride.

What is the NDC code for Mouth Rinse .1 mg/mL?

The NDC (National Drug Code) for Mouth Rinse .1 mg/mL is 36800-001, listed by Topco Associates LLC.

Product NDC

36800-001

Package NDC

36800-001-86

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)