stance

Generic: 0.63% stannous fluoride concentrate rinse

Labeler: elevate oral care
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name stance
Generic Name 0.63% stannous fluoride concentrate rinse
Labeler elevate oral care
Dosage Form RINSE
Routes
TOPICAL
Active Ingredients

stannous fluoride 1.2 mg/mL

Manufacturer
Elevate Oral Care

Identifiers & Regulatory

Product NDC 57511-0201
Product ID 57511-0201_3f683700-1d54-5536-e063-6394a90a73ec
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2016-08-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 575110201
Hyphenated Format 57511-0201

Supplemental Identifiers

RxCUI
583459
UNII
3FTR44B32Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name stance (source: ndc)
Generic Name 0.63% stannous fluoride concentrate rinse (source: ndc)
Application Number M021 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.2 mg/mL
source: ndc
Packaging
  • 225 mL in 1 BOTTLE, PUMP (57511-0201-1)
source: ndc

Packages (1)

57511-0201-1 225 mL in 1 BOTTLE, PUMP (57511-0201-1)

Ingredients (1)

stannous fluoride (1.2 mg/mL)

Linked Drug Pages (1)

Stance ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3f683700-1d54-5536-e063-6394a90a73ec", "openfda": {"unii": ["3FTR44B32Q"], "rxcui": ["583459"], "spl_set_id": ["3ae71258-a8c2-6eb5-e054-00144ff88e88"], "manufacturer_name": ["Elevate Oral Care"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "225 mL in 1 BOTTLE, PUMP (57511-0201-1)", "package_ndc": "57511-0201-1", "marketing_start_date": "20160825"}], "brand_name": "Stance", "product_id": "57511-0201_3f683700-1d54-5536-e063-6394a90a73ec", "dosage_form": "RINSE", "product_ndc": "57511-0201", "generic_name": "0.63% Stannous Fluoride Concentrate Rinse", "labeler_name": "Elevate Oral Care", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Stance", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": "1.2 mg/mL"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160825", "listing_expiration_date": "20261231"}