Home NDC 43498-151 Burkhart Neutral pH
Product NDC 43498-151
11-digit product format 434980151
Labeler code 43498
Product ID 43498-151_d70d625c-edfa-6184-e053-2a95a90ac93a
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 4.086 g/454g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Burkhart Neutral pH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 4.086 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245593 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43498-151-15 Burkhart Neutral pH 454 g in 1 BOTTLE, PLASTIC GEL 454 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43498-151 BURKHART NEUTRAL PH (SODIUM FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC] 3 Current NDC, Legacy NDC, 1 package rows 20220203_0fb4d584-36e8-4db7-b72e-04608580dacd.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 43498-151-15 43498015115 454 g in 1 BOTTLE, PLASTIC (43498-151-15) 454 g 2013-09-01 0000-00-00 No No Current