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 19 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Povi-One POVIDONE-IODINE 10% TOPICAL Elevate Oral Care f5252b4f-5e14-509e-e053-2995a90a6db8 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f199947-bf25-914b-e063-6394a90a8a6f 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f199947-bf28-914b-e063-6394a90a8a6f 2025-09-18 Warnings Exact identifier application number: M022 Patterson Dental Topical Anesthetic BENZOCAINE Patterson Dental 3f19a1a7-c234-8d26-e063-6394a90ad7e9 2025-09-18 Warnings Exact identifier application number: M022 McKesson Orasol Gel BENZOCAINE 20% McKesson Medical-Surgical cc8724f4-c482-5e7d-e053-2a95a90a608f 2025-09-09 Warnings Exact identifier application number: M022 MGC Health Drops Sugar Free Lemon Mint MENTHOL Medical Group Care LLC 3d70bca7-e830-e693-e063-6294a90a73f9 2025-08-28 Warnings Exact identifier application number: M022 Exchange Select Drops Sugar Free Lemon Mint MENTHOL Army & Air Force Exchange Service 3d70450f-04ea-1885-e063-6294a90a05bd 2025-08-28 Warnings Exact identifier application number: M022 Ki No Sin CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 21fa2bad-5b8b-8aac-e063-6394a90a9f49 2025-08-27 Warnings Exact identifier application number: M022 R Cos CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 21fa767a-1344-5ed9-e063-6394a90a5fe6 2025-08-27 Warnings Exact identifier application number: M022 Na Mi Cal CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 20cfbcd1-eb13-933c-e063-6294a90a7e59 2025-08-27 Warnings Exact identifier application number: M022 Ki No Sin CALCIUM CARBONATE NPG Bio Pharmaceuticals Co.,Ltd. 20cf8f80-c638-4d94-e063-6294a90a5400 2025-08-27 Warnings Exact identifier application number: M022 Charm Tex FLUORIDE SODIUM MONOFLUOROPHOSPHATE Yangzhou Hongshengding Chemical Co.,Ltd. 63a69664-8611-4d69-b871-8d1d5b553e5c 2025-08-18 Warnings Exact identifier application number: M022 QUALITY CHOICE SALINE SODIUM CHLORIDE QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) f51491d8-12ad-4b1b-a171-c621bfdcc341 2025-08-12 Warnings Exact identifier application number: M022 MGC Health Drops Sugar Free Lemon Mint MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. b9227966-847c-40c3-87f2-8bea3954ec84 2025-08-12 Warnings Exact identifier application number: M022 Exchange Select Drops Sugar Free Lemon Mint MENTHOL Xiamen Kang Zhongyuan Biotechnology Co., Ltd. 5f4b1960-43ac-4c74-9410-210c48bd8a1b 2025-08-12 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 113cdb83-0fdd-40f2-8ee6-b771dca99713 2025-08-12 Warnings Exact identifier application number: M022 CVS Pharmacy Maximum Strength BENZOCAINE CVS Pharmacy 13bf31c1-78e3-459f-9249-b0b6e2c17a13 2025-08-12 Warnings Exact identifier application number: M022 Rexall Maximum Strength BENZOCAINE Rexall 8f6e2780-cfb7-4bef-9b7d-13cb80d8923e 2025-08-12 Warnings Exact identifier application number: M022 Walgreens Maximum Strength BENZOCAINE Walgreens 8f24309d-d393-455a-a9a5-a55344adf36b 2025-08-12 Warnings Exact identifier application number: M022 Oral Anesthetic Liquid BENZOCAINE Meijer, Inc. 0321c480-e150-421d-e063-6294a90ad687 2025-08-12 Warnings Exact identifier application number: M022
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