Home NDC 43498-104 Burkhart
Product NDC 43498-104
11-digit product format 434980104
Labeler code 43498
Product ID 43498-104_d70e4c68-dc7d-43e0-e053-2995a90acd86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL
Route DENTAL
Labeler Burkhart Dental Supply Inc
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2012-12-14
Substance SODIUM FLUORIDE
Active strength 5.6 g/454g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burkhart SODIUM FLUORIDE Burkhart Dental Supply Inc d7422939-c28e-4bda-b679-81abcc8c36e2 2022-02-02 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings: Keep out of reach of children. Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. Read directions carefully before using.
Additional Listing Data#
Finished product Yes
Brand name base Burkhart
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 5.6 g/454g
Harmonized Identifiers# Field, Values table Field Values Unii 8ZYQ1474W7
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43498-104-15 Burkhart 454 g in 1 BOTTLE, PLASTIC GEL 454 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43498-104 BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC] 4 Current NDC, Legacy NDC, 1 package rows 20220203_d7422939-c28e-4bda-b679-81abcc8c36e2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43498-104-15 43498010415 454 g in 1 BOTTLE, PLASTIC (43498-104-15) 454 g 2013-09-01 0000-00-00 No No Current