EverSmile AlignerFresh Enamel Guard

Product NDC
72655-300
11-digit product format
726550300
Labeler code
72655
Product ID
72655-300_b07956ac-7866-4a89-b2cb-bf502590101d
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
RINSE
Route
ORAL
Labeler
Everbrands, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-16
Substance
SODIUM FLUORIDE
Active strength
.225 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EverSmile AlignerFresh Enamel Guard
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.225 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui2597250

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72655-300EVERSMILE ALIGNERFRESH ENAMEL GUARD (SODIUM FLUORIDE) RINSE [EVERBRANDS, INC.]1Current NDC, Legacy NDC, 2 package rows20220330_7b3d0114-dac0-4370-8545-922ec018018e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2597250sodium fluoride 0.05 % Oral FoamPSN7b3d0114-dac0-4370-8545-922ec018018e2
2597250sodium fluoride 0.5 MG/ML Oral FoamSCD7b3d0114-dac0-4370-8545-922ec018018e2
2597250sodium fluoride 0.05 % (fluoride ion 0.0225 % ) Oral FoamSY7b3d0114-dac0-4370-8545-922ec018018e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72655-300-01726550300011 BOTTLE, PUMP in 1 PACKAGE (72655-300-01) / 50 mL in 1 BOTTLE, PUMP2022-02-160000-00-00NoNoCurrent