burkhart

Generic: stannous fluoride

Labeler: burkhart dental supply inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name burkhart
Generic Name stannous fluoride
Labeler burkhart dental supply inc
Dosage Form GEL
Routes
DENTAL
Active Ingredients

stannous fluoride .116 g/120g

Manufacturer
Burkhart Dental Supply Inc

Identifiers & Regulatory

Product NDC 43498-250
Product ID 43498-250_2b483c18-3a2d-1701-e063-6294a90a3f49
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2013-01-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43498250
Hyphenated Format 43498-250

Supplemental Identifiers

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 burkhart (source: ndc)
Generic Name stannous fluoride (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • .116 g/120g
source: ndc
Packaging
  • 120 g in 1 TUBE (43498-250-04)
source: ndc

Packages (1)

43498-250-04 120 g in 1 TUBE (43498-250-04)

Ingredients (1)

stannous fluoride (.116 g/120g)

Linked Drug Pages (1)

Burkhart ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2b483c18-3a2d-1701-e063-6294a90a3f49", "openfda": {"unii": ["3FTR44B32Q"], "spl_set_id": ["048c9978-e32e-4f77-9a4e-40acd5fcdfaf"], "manufacturer_name": ["Burkhart Dental Supply Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 g in 1 TUBE (43498-250-04)", "package_ndc": "43498-250-04", "marketing_start_date": "20130901"}], "brand_name": "Burkhart", "product_id": "43498-250_2b483c18-3a2d-1701-e063-6294a90a3f49", "dosage_form": "GEL", "product_ndc": "43498-250", "generic_name": "Stannous Fluoride", "labeler_name": "Burkhart Dental Supply Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Burkhart", "active_ingredients": [{"name": "STANNOUS FLUORIDE", "strength": ".116 g/120g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130105", "listing_expiration_date": "20261231"}