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 |
|---|---|
| STANNOUS FLUORIDE | .116 g/120g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6d8078e9-b0d8-4220-b90a-3f14fa0e43f4 | Available on FDA.report |
DailyMed Package Descriptions#
| 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 | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Crest Kids Advanced Color Changing | SODIUM MONOFLUOROPHOSPHATE | Procter & Gamble Manufactura, S de R.L. de C.V. | fc86b98e-d556-4769-e053-6394a90afc6e | 2026-01-08 | Warnings | M022 |
| Care One Maximum Strength | FLUORIDE | American Sales | 1b6618ea-6533-41d7-be2c-13bb9e108dc5 | 2026-01-08 | Warnings | M022 |
| equate Sensitive | POTASSIUM NITRATE, SODIUM FLUORIDE | Wal-Mart Stores Inc | 79899b59-3a16-6504-e053-2991aa0a895a | 2026-01-08 | Warnings | M022 |
| Crest Kids Advanced Color Changing | SODIUM MONOFLUOROPHOSPHATE | Procter & Gamble Manufactura, S de R.L. de C.V. | 451283d3-78b0-8361-e063-6294a90a1fd5 | 2026-01-08 | Warnings | M022 |
| CVS Maximum Strength | BENZOCAINE | CVS Pharmacy | 8691d6b6-741e-47b2-8332-76742b34715f | 2026-01-08 | Warnings | M022 |
| 4x Medicated Toothache and Gum Gel | BENZOCAINE | Publix Super Markets INC | 16eb9d15-dba3-36e6-e063-6394a90ab859 | 2026-01-08 | Warnings | M022 |
| Toothache and Gum Relief | BENZOCAINE, MENTHOL | CVS Pharmacy | 814ec7bf-f825-1095-e053-2a91aa0aee59 | 2026-01-08 | Warnings | M022 |
| Lemon | GLYCERIN | Sion Biotext Medical Ltd | dbd7ed86-1b92-4471-827a-89f3afa1b0dc | 2026-01-08 | Warnings | M022 |
| Sootheez Organic Wild Cherry | PECTIN | BFY LLC | 47baa2a8-270c-fa07-e063-6394a90a97f6 | 2026-01-06 | Warnings | M022 |
| Parodontax Gum Strengthen and Protect | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 3bb378c8-14b2-aa13-e063-6294a90a4db3 | 2026-01-05 | Warnings | M022 |
| MySweetSmile Toothpaste. | MYSWEETSMILE TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 478baf87-9276-7288-e063-6294a90a9e8e | 2026-01-04 | Warnings | M022 |
| MySweetSmile Mango Toothpaste. | MYSWEETSMILE MANGO TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 478cbdeb-28e1-fa56-e063-6294a90af124 | 2026-01-04 | Warnings | M022 |
| Smile Paint | SODIUM FLUORIDE | JABBER JAW KIDS TOOTHPASTE LLC | a7463b5c-53b2-4353-a5ea-800fbd7bd17d | 2026-01-02 | Warnings | M022 |
| Dentek Canker Cover | MENTHOL | Bershtel Enterprises | 2669183c-7a58-037e-e054-00144ff88e88 | 2025-12-31 | Warnings | M022 |
| AutoBrush strawberry | SODIUM FLUORIDE | Lander Enterprises, LLC | 05929148-bffe-439f-a9d4-3170816c0fa2 | 2025-12-31 | Warnings | M022 |
| AutoBrush Watermelon | SODIUM FLUORIDE | Lander Enterprises, LLC | 37a4e712-e3b5-42f6-971c-98dea4b8dd06 | 2025-12-31 | Warnings | M022 |
| AutoBrush Mint | SODIUM FLUORIDE | Lander Enterprises, LLC | 6bcd35f5-18ea-4fc8-84cd-06db73f38a1e | 2025-12-31 | Warnings | M022 |
| AutoBrush Bubblegum | SODIUM FLUORIDE | Lander Enterprises, LLC | e7bf7e31-650d-4a1c-9100-48722344b201 | 2025-12-31 | Warnings | M022 |
| Normal Salt | SODIUM CHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | f3f09817-8a38-4aa1-956b-69d9cf695074 | 2025-12-25 | Warnings | M022 |
| Sensitive Mint Tooth-paste | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | 1e5e8b24-8304-482c-ae80-73effcc345da | 2025-12-23 | Warnings | M022 |
Packages#
| 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 |