Home NDC 43498-251 Burkhart
Product NDC 43498-251
11-digit product format 434980251
Labeler code 43498
Product ID 43498-251_2b482a60-20e3-e4ce-e063-6294a90ac004
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form GEL
Route DENTAL
Labeler Burkhart Dental Supply Inc
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-01-05
Substance STANNOUS FLUORIDE
Active strength .116 g/120g
NDC exclude flag No
Listing certified through 2026-12-31
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 Burkhart
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .116 g/120g
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 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 43498-251-04 Burkhart 120 g in 1 TUBE GEL 120 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43498-251 BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC] 5 Current NDC, Legacy NDC, 1 package rows 20250112_6d8078e9-b0d8-4220-b90a-3f14fa0e43f4.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 15 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43498-251-04 43498025104 120 g in 1 TUBE (43498-251-04) 120 g 2013-09-01 0000-00-00 No No Current