FDA.reportPublic FDA data

ORTHOFOAM ANTICAVITY BRACES CLEANING FOAM

Manufacturer
Everbrands, Inc.
Effective date
2026-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:54:16

Label at a glance#

ProductEversmile OrthoFoam Anticavity
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

•aids in the prevention of dental cavities

Dosage and administration

To Brush: •Dispense 1-2 pumps of foam onto a toothbrush. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician EverSmile Traybrush application: •Adults and children 12 yrs. of age and older: •Dispense 1-2 pumps of foam onto each side of the TrayBrush. •Insert the foam-filled Traybrush into your mouth. Gently bite up and down, and move the handle side t...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride....... 0.05%

(0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

•aids in the prevention of dental cavities

​​Warnings

WARNINGS SECTION

​Stop use and ask dentist if ​oral irritation or tooth sensitivity occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children. If more than used for rinsing is

accidentally swallowed, get medical help or contact a Poison

Control Center right away.

​Directions:

DOSAGE & ADMINISTRATION SECTION

To Brush:

•Dispense 1-2 pumps of foam onto a toothbrush. Brush teeth

thoroughly, preferably after each meal or at least twice a day,

or as directed by a dentist or physician

EverSmile Traybrush application:

•Adults and children 12 yrs. of age and older:

•Dispense 1-2 pumps of foam onto each side of the TrayBrush.

•Insert the foam-filled Traybrush into your mouth. Gently bite

up and down, and move the handle side to side for approximately 

2 minutes to clean.

•If needed, remove the TrayBrush to spit out

excess foam- do not swallow, then reinsert

it immediately.

•Option: after brushing keep the TrayBrush in

contact with your teeth for up to 5 minutes

to enhance the therapeutic benefits.

•Use daily or as directed by your dentist.

•Children under 12 years of age: consult a dentist or doctor

Other information

OTHER SAFETY INFORMATION

store at controlled room temperature 

68-77°F(20-25°)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, hydrogen peroxide, PVP, PEG, glycerin, sucralose,

sodium lauryl sulfate, natural bubble gum flavor, sodium

citrate, sodium benzoate

OTC - QUESTIONS SECTION

​Questions? +​1(855)595-2999

EverSmile® ORTHOFOAM ANTICAVITY BRACES CLEANING FOAM Labelinh

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

------------------------------------------

EverSmile​®

​ORTHOFOAM

  ANTICAVITY

     BRACES

CLEANING FOAM

Bubble gum​

​0.05% Sodium Fluoride             50 mL (1.69 fl oz)

Manufactured By

EverBrands, Inc

11791 Monarch St

Garden Grove,

CA 92841

(855)595-2999

info@eversmilewhite.com

eversmilewhite.com

outer packageouter package

Inner packageInner package

RES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2597250sodium fluoride 0.05 % Oral FoamPSN1
2597250sodium fluoride 0.5 MG/ML Oral FoamSCD1
2597250sodium fluoride 0.05 % (fluoride ion 0.0225 % ) Oral FoamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72655-600-01Eversmile OrthoFoam Anticavity50 mL in 1 BOTTLE, PUMPLIQUID501
72655-600-01Eversmile OrthoFoam Anticavity1 in 1 BOXLIQUID11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72655-60072655-600-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
PVPFZ989GH94EIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eversmile OrthoFoam Anticavity0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.9c12e792-94c8-4e29-9a54-e7e70aadade62026-04-16WarningsExact identifier
ndc (package): 72655-600-01
ndc (product): 72655-600
ndc11 (package): 72655060001
spl id: cb1b1057-9f4f-4ff3-ab9c-b150261dc39a
spl set id: 9c12e792-94c8-4e29-9a54-e7e70aadade6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.