Drugplain

ANTICAVITY FLUORIDE .05 g/100mL

SODIUM FLUORIDE · LIQUID · Kingkey MBC Life Technology Group co., LTD

10 Recalls on RecordCurrently in Shortage
Plain English

ANTICAVITY FLUORIDE is a liquid containing sodium fluoride at .05 g/100mL, taken oral. Manufactured by Kingkey MBC Life Technology Group co., LTD.

Key Facts

Brand Name
ANTICAVITY FLUORIDE
Generic Name
SODIUM FLUORIDE
NDC Code (Product)
73928-090
Manufacturer
Kingkey MBC Life Technology Group co., LTD
Strength
.05 g/100mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M021
Marketing Start
12/01/2024

Recall History

10 Recalls on Record
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/10/2022

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

OngoingVoluntary: Firm initiated
Class II08/10/2022

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

OngoingVoluntary: 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 II09/06/2012

Church & Dwight Inc

CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II08/10/2022

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

OngoingVoluntary: Firm initiated
Class II08/10/2022

Family Dollar Stores, Llc.

cGMP deviation: Product held outside of appropriate temperature storage conditions.

OngoingVoluntary: Firm initiated
Class III06/06/2014

Estee Lauder Inc

Stability Data Does Not Support Expiry

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

pyrexia170 reports
fatigue159 reports
nausea159 reports
vomiting156 reports
pain155 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 helps protect teeth against cavities.

Dosage & Administration

Directions Adults and children 6 years of age and older: • Use once a day after brushing your teeth with a toothpaste​. • Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. • Do Not swallow the rinse. • Do Not eat or drink for 30 minutes after rinsing. • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). • Supervise children as necessary until capable of using without supervision. • Children under 6 years of age: Consult a dentist or doctor.

Warnings

Warnings Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for rinsing, call professional help at 1-800-222-1222 or go to PoisonHelp.org.

Frequently Asked Questions

What is ANTICAVITY FLUORIDE used for?

ANTICAVITY FLUORIDE contains SODIUM FLUORIDE. It is a liquid taken oral. Consult your doctor for specific uses.

Is ANTICAVITY FLUORIDE a controlled substance?

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

What is the generic name for ANTICAVITY FLUORIDE?

The generic name for ANTICAVITY FLUORIDE is SODIUM FLUORIDE. There are 12 other brand versions of SODIUM FLUORIDE.

What is the NDC code for ANTICAVITY FLUORIDE .05 g/100mL?

The NDC (National Drug Code) for ANTICAVITY FLUORIDE .05 g/100mL is 73928-090, listed by Kingkey MBC Life Technology Group co., LTD.