FDA.reportPublic FDA data

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
IngredientStrength
STANNOUS FLUORIDE.116 g/120g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d8078e9-b0d8-4220-b90a-3f14fa0e43f4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43498-251-04Burkhart120 g in 1 TUBEGEL1205

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Stannous FluorideACTIVE INGREDIENT3FTR44B32QBURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Fluoride IonACTIVE MOIETYQ80VPU408OBURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EBURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Malic AcidINACTIVE INGREDIENT817L1N4CKPBURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
WaterINACTIVE INGREDIENT059QF0KO0RBURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEBURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43498-251BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]5Current NDC, Legacy NDC, 1 package rows20250112_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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore Mouth CleanserHYDROGEN PEROXIDEMeijer, Inc.c9c17224-9304-403a-b6a1-9c8bd94e3d942026-02-19Warnings, Adverse reactionsExact identifier
application number: M022
AQUAFRESH CAVITY PROTECTIONSODIUM FLUORIDEHaleon US Holdings LLC5484999c-8e6f-430d-99a5-6893a24894672026-02-16WarningsExact identifier
application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
application number: m022
Sore Mouth CleanserHYDROGEN PEROXIDEWalgreen Co.33223589-4ff4-4e4e-96da-6fa2e4d0f1872026-02-12Warnings, Adverse reactionsExact identifier
application number: M022
PERIOSCIENCES SENSITIVE AO ProPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLCacca8964-b575-468c-8b40-514dfbf507782026-02-09WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLRetail Business Services, LLCd46546d0-c6df-431a-8ab0-bc5013c084d72026-02-06Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)e19228e9-6f87-456e-a222-f979a234d5892026-02-06WarningsExact identifier
application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
application number: M022
Sootheez Strawberry LemonadePECTINPrimrose Candy Co.49e2b303-1018-cd13-e063-6394a90ae3002026-02-02WarningsExact identifier
application number: M022
Sootheez Berry LemonadePECTINPrimrose Candy Co.49cee56f-c45f-6c79-e063-6294a90a5f8f2026-02-01WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDERite Aid Corporation294418aa-640d-42be-ad07-de31da7a7ccc2026-01-30Warnings, Adverse reactionsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company866067b9-3dce-492d-ae99-1b807ecd56ff2026-01-22WarningsExact identifier
application number: M022
Family Wellness Pain ReliefBENZOCAINE 20%FAMILY DOLLAR (Family Wellness)92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea2026-01-21WarningsExact identifier
application number: M022
Crest Pro-Health All Day Clean BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company48eaca4c-19c2-2dd2-e063-6394a90a3e082026-01-21WarningsExact identifier
application number: M022
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINEUniversal Distribution Center LLCe276ba37-46fb-4ed9-9ee1-c08a2a89704a2026-01-20WarningsExact identifier
application number: M022
Equate Orasol20% BENZOCAINEWAL-MART STORES INC.08404780-8252-4484-b1c3-8970803f74f82026-01-19WarningsExact identifier
application number: M022
Equate Healthy MouthCPC 0.05% ANTIPLAQUE/ANTI-GINGIVITISWalmart, Inc.1cc1f6fd-67d4-b314-e063-6294a90ab9952026-01-19WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43498-251-0443498025104120 g in 1 TUBE (43498-251-04) 120 g2013-09-010000-00-00NoNoCurrent