Stance

Product NDC
57511-0201
11-digit product format
575110201
Labeler code
57511
Product ID
57511-0201_4cc1428e-fdc7-a943-e063-6394a90af86b
Type
HUMAN OTC DRUG
Nonproprietary name
0.63% Stannous Fluoride Concentrate Rinse
Dosage form
RINSE
Route
TOPICAL
Labeler
Elevate Oral Care
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-25
Substance
STANNOUS FLUORIDE
Active strength
1.2 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
Stance
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui583459

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57511-0201-1Stance225 mL in 1 BOTTLE, PUMPRINSE22513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57511-0201STANCE (0.63% STANNOUS FLUORIDE CONCENTRATE RINSE) RINSE [ELEVATE ORAL CARE]11Current NDC, Legacy NDC, 1 package rows20231031_3ae71258-a8c2-6eb5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
583459stannous fluoride 0.63 % Dental SolutionPSN3ae71258-a8c2-6eb5-e054-00144ff88e8813
583459stannous fluoride 6.3 MG/ML MouthwashSCD3ae71258-a8c2-6eb5-e054-00144ff88e8813
583459stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental SolutionSY3ae71258-a8c2-6eb5-e054-00144ff88e8813
583459stannous fluoride 0.63 % Dental SolutionSY3ae71258-a8c2-6eb5-e054-00144ff88e8813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57511-0201-157511020101225 mL in 1 BOTTLE, PUMP (57511-0201-1) 225 ml2016-08-250000-00-00NoNoCurrent