Home NDC 57511-0201 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Stance
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE 1.2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 583459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57511-0201-1 Stance 225 mL in 1 BOTTLE, PUMP RINSE 225 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57511-0201 STANCE (0.63% STANNOUS FLUORIDE CONCENTRATE RINSE) RINSE [ELEVATE ORAL CARE] 11 Current NDC, Legacy NDC, 1 package rows 20231031_3ae71258-a8c2-6eb5-e054-00144ff88e88.zip
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 35 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57511-0201-1 57511020101 225 mL in 1 BOTTLE, PUMP (57511-0201-1) 225 ml 2016-08-25 0000-00-00 No No Current