Home NDC 43498-103 Burkhart
Product NDC 43498-103
11-digit product format 434980103
Labeler code 43498
Product ID 43498-103_d70e42c6-8627-53b4-e053-2a95a90a4971
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 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 SODIUM FLUORIDE 5.6 g/454g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 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 43498-103-15 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 43498-103 BURKHART (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC] 4 Current NDC, Legacy NDC, 1 package rows 20220203_79fa0a42-bb69-49db-9997-1679a75bac26.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43498-103-15 43498010315 454 g in 1 BOTTLE, PLASTIC (43498-103-15) 454 g 2013-09-01 0000-00-00 No No Current