Home NDC 43498-200 Burkhart
Product NDC 43498-200
11-digit product format 434980200
Labeler code 43498
Product ID 43498-200_d70dcc83-25ca-3eb9-e053-2a95a90a5c02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Stannous Fluoride
Dosage form CONCENTRATE
Route DENTAL
Labeler Burkhart Dental Supply Inc
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2013-02-01
Substance STANNOUS FLUORIDE
Active strength .3408 g/284g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Burkhart
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .3408 g/284g
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 43498-200-10 Burkhart 284 g in 1 BOTTLE, PLASTIC CONCENTRATE 284 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43498-200 BURKHART (STANNOUS FLUORIDE) CONCENTRATE [BURKHART DENTAL SUPPLY INC] 3 Current NDC, Legacy NDC, 1 package rows 20220203_de19f0ea-7446-493d-b766-c678c727a1af.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 1 of 1 · 1 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 43498-200-10 43498020010 284 g in 1 BOTTLE, PLASTIC (43498-200-10) 284 g 2013-09-01 0000-00-00 No No Current