FDA.reportPublic FDA data

ALIGNERFRESH ENAMEL GUARD FLUORIDE FOAM

Manufacturer
Everbrands, Inc.
Effective date
2026-04-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:54:26

Label at a glance#

ProductEverSmile AlignerFresh Enamel Guard
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - PURPOSE SECTION

Purpose

Anticavity

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium fluoride 0.05%

(0.0225% w/v fluoride ion)

INDICATIONS & USAGE SECTION

Uses

  • aids in prevention of dental cavities

WARNINGS SECTION

Warnings

Stop use and ask a 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.

DOSAGE & ADMINISTRATION SECTION

Directions:

Tray application

  • Adults and children 12 yrs. of age and older:
  • Dispense up to a full pump of foam inside each tray.
  • Use the nozzle tip to cover all areas of the tray evenly with foam.
  • Place form-filled trays back in mouth.
  • Spit out excess.
  • No need to rinse as foam naturally dissipates.
  • Do not swallow rinse.
  • Children under 12 years of age: consult a dentist or doctor.

To rinse:

  • Adults and children 12 years & older:
  • Use twice a day after brushing your teeth with a toothpaste.
  • Vigorously swish 2 pumps 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 12 years of age: consult a dentist or doctor.

OTHER SAFETY INFORMATION

Other Information store at controlled room temperature 68-77°F (20 - 25°C)

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Etidronic Acid, glycerin, hydrogen peroxide,
menthe arvensis oil, PEG, PVP, sodium
benzoate, sodium citrate, sodium lauryl sulfate.
sucralose, water

OTC - QUESTIONS SECTION

Questions?  +1 (855) 595-2999

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EverSmile®

ALIGNERFRESH

ENAMEL
GUARD

FLUORIDE FOAM

50 mL (1.69fl oz)

Manufactured By
EverBrands, Inc. 401 N Oak St.
Inglewood, CA 90302

855 595-2999
info@eversmilewhite.com
www.eversmilewhite.com

Box Label

300 Box300 Box

Bottle Label

300 Bottle Label300 Bottle Label

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2597250sodium fluoride 0.05 % Oral FoamPSN2
2597250sodium fluoride 0.5 MG/ML Oral FoamSCD2
2597250sodium fluoride 0.05 % (fluoride ion 0.0225 % ) Oral FoamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
07cba15c-4adc-1039-9ab9-45f5b7e84f4fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72655-300-012023-07-28C16284748780-10191ceaa-618a-198a-e063-dbdaa90aec3eALIGNERFRESH ENAMEL GUARD FLUORIDE FOAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72655-300-01EverSmile AlignerFresh Enamel Guard50 mL in 1 BOTTLE, PUMPRINSE502
72655-300-01EverSmile AlignerFresh Enamel Guard1 in 1 PACKAGERINSE12

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72655-30072655-300-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
ETIDRONIC ACIDM2F465ROXUIACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
MENTHA ARVENSIS FLOWER OILQ129Z1W6Y2IACT
POLYETHYLENE GLYCOL 8000Q662QK8M3BIACT
POVIDONE K30U725QWY32XIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SUCRALOSE96K6UQ3ZD4IACT
WATER059QF0KO0RIACT

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 AlignerFresh Enamel GuardSODIUM FLUORIDEEverbrands, Inc.7b3d0114-dac0-4370-8545-922ec018018e2026-04-21WarningsExact identifier
ndc (package): 72655-300-01
ndc (product): 72655-300
ndc11 (package): 72655030001
spl id: b07956ac-7866-4a89-b2cb-bf502590101d
spl set id: 7b3d0114-dac0-4370-8545-922ec018018e

Reported adverse events (FAERS/openFDA)#

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