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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6d8078e9-b0d8-4220-b90a-3f14fa0e43f4	Available on FDA.report

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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Stannous Fluoride	ACTIVE INGREDIENT	3FTR44B32Q	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1
Malic Acid	INACTIVE INGREDIENT	817L1N4CKP	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	BURKHART (STANNOUS FLUORIDE) GEL [BURKHART DENTAL SUPPLY INC]	1

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 17 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART SALINE	SALINE NASAL (SODIUM CHLORIDE)	WALMART STORES INC	06906744-49a5-4bab-8539-af2d235df9e8	2025-10-28	Warnings	Exact identifier application number: M022
Saline	NASAL	PUBLIX SUPER MARKETS, INC	19841567-9511-43d6-ba4e-d1e1bd3481a4	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Fast Relief Oral Anesthetic	PHENOL	PUBLIX SUPER MARKETS, INC	89291f12-bbc3-4472-8ad3-a34485af72c9	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Menthol Flavor	PHENOL	PUBLIX SUPER MARKETS, INC	9296c49e-557c-43ed-9527-fcba5093a8dc	2025-10-28	Warnings	Exact identifier application number: M022
WinCo Foods Maximum Strength Oral Analgesic	BENZOCAINE	WinCo Foods, LLC	c22a7726-8c3f-41bf-b852-8456b2be6f93	2025-10-28	Warnings	Exact identifier application number: M022
Rugby Cherry Flavor	PHENOL	RUGBY LABORATORIES	3d668c78-8130-45d4-bcb7-dddcb2fbe7a3	2025-10-25	Warnings	Exact identifier application number: M022
LolliCaine Bubble Gum	BENZOCAINE	Centrix, Inc.	56ae3a84-6bca-4906-a03d-9d755e1fba3b	2025-10-24	Warnings	Exact identifier application number: M022
Diabetic Tussin Sore Throat Cherry	PHENOL	MEDTECH PRODUCTS INC	ab351229-5771-4c6c-92a8-721cc41c002f	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar Free	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	34e4234c-ed61-4795-99fe-d281cdb0af88	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	6b1a50d0-be54-4fcb-b5e2-b47abf3555c0	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Childrens Sore Throat Cherry	PHENOL	Prestige Brands Holdings, Inc.	38ff6922-1abe-4fa9-a74e-ede604f707b5	2025-10-23	Warnings	Exact identifier application number: M022
Boka Sensitive	POTASSIUM NITRATE	Karaka LLC	40be9fab-53db-c67a-e063-6394a90a48cb	2025-10-23	Warnings	Exact identifier application number: M022
Canker Care Plus	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	1ec960db-52d5-4d99-a7f7-a2e538d28724	2025-10-20	Warnings	Exact identifier application number: M022
meijer Sensitive EXTRA WHITENING	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	bbcffb88-0bd4-4883-bb83-0b7a1428ad12	2025-10-20	Warnings	Exact identifier application number: M022
Quality Choice Maximum Strength Oral Pain Relieving	BENZOCAINE	Chain Drug Marketing Association Inc	dbde8e7f-85d8-4083-b01a-3a7e410a7747	2025-10-17	Warnings	Exact identifier application number: M022
Quality Choice	BENZOCAINE	Chain Drug Marketing Association, Inc.	24c3c4a3-bd76-198d-e063-6394a90ad45a	2025-10-16	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Cardinal Health	b84203bd-23e9-427d-83d8-f4c88266e23c	2025-10-14	Warnings	Exact identifier application number: M022
Finafta	BENZOCAINE, GLYCERIN	Efficient Laboratories Inc.	03368603-3e11-c2fa-e063-6294a90a04ea	2025-10-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening Action	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	e8a62f24-1db6-45fb-b6e1-5e57103f82bc	2025-10-14	Warnings	Exact identifier application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT	POTASSIUM NITRATE, SODIUM FLUORIDE	Ashtel Studios, Inc.	bc74d2a6-fe34-44cf-b015-70ed4d47c933	2025-10-13	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3FTR44B32Q	STANNOUS FLUORIDE	7783-47-3	STANNOUS FLUORIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Burkhart - Burkhart Dental Supply Inc	Burkhart Dental Supply Inc	2025-01-09	HUMAN OTC DRUG LABEL	5