FDA.reportPublic FDA data

Stance

Manufacturer
Elevate Oral Care
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:49:36

Label at a glance#

ProductStance
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsActive Ingredients

Uses INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

UsesUses

WARNINGS

WARNINGS SECTION

WarningsWarnings

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of ChildrenKeep Out of Reach of Children

Directions INSTRUCTIONS FOR USE SECTION

INSTRUCTIONS FOR USE SECTION

DirectionsDirections

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

Questions?

OTC - QUESTIONS SECTION

QuestionsQuestions

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Other Information

OTHER SAFETY INFORMATION

Other InformationOther Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Package LabelPrimary Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
583459stannous fluoride 0.63 % Dental SolutionPSN13
583459stannous fluoride 6.3 MG/ML MouthwashSCD13
583459stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental SolutionSY13
583459stannous fluoride 0.63 % Dental SolutionSY13

DailyMed Package Descriptions#

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

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57511-020157511-0201-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML · Source PDF

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
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
ndc (package): 57511-0201-1
ndc (product): 57511-0201
ndc11 (package): 57511020101
spl id: 4cc1428e-fdc7-a943-e063-6394a90af86b
spl set id: 3ae71258-a8c2-6eb5-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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