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 |
|---|---|---|---|---|---|---|
| Oral Gel Oral Pain Relief | BENZOCAINE BENZALKONIUM CHLORIDE | Savvy Care and Cosmetics | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2024-12-19 | Warnings | M022 |
| EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint | SODIUM BICARBONATE | Lotus Brands, Inc. | 4a95c8c1-db7c-4791-ac58-3eac216a0126 | 2024-12-18 | Warnings | M022 |
| EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon | SODIUM BICARBONATE | Lotus Brands, Inc. | 6703b29d-cdc9-4c74-91c0-fb0c98dd043e | 2024-12-18 | Warnings | M022 |
| Red Cross Oral Pain Relief | BENZOCAINE | The Mentholatum Company | cbd41429-f730-4577-9f06-ef1831cf62e1 | 2024-12-17 | Warnings | M022 |
| Red Cross Canker Sore | BENZOCAINE | The Mentholatum Company | 54cfff96-6665-4b36-a15d-10bf6cf3a1f9 | 2024-12-17 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | 116956644 | 2981217f-f250-c090-e063-6294a90a85b0 | 2024-12-17 | Warnings | M022 |
| Kank-A Mouth Pain | BENZOCAINE | Blistex Inc. | eebc03ba-f849-4e70-a653-834f383b6aa4 | 2024-12-17 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8282a4a6-b77c-75fc-e053-2991aa0ad4ac | 2024-12-16 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | 9452bff4-8c08-eff9-e053-2a95a90a67ed | 2024-12-16 | Warnings | M022 |
| PHENOL | PHENOL | CHAIN DRUG MARKETING ASSOCIATION INC. | 2379e23a-72fe-4e94-9d7e-9b623c0db174 | 2024-12-13 | Warnings | M022 |
| KANKA SoftBrush | BENZOCAINE AND ZINC CHLORIDE | Blistex Inc | 093f3545-1d8e-48a3-a533-e9c3ae6d740b | 2024-12-12 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 826eaef8-4457-3dc2-e053-2991aa0a528b | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8281700c-10f9-841c-e053-2991aa0a918f | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | e3da0e63-a891-72bd-e053-2a95a90a58bc | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories, Inc. | e3d924b5-0788-46d3-e053-2995a90a027b | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | fa433031-7376-0e5b-e053-6394a90a5f75 | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | eedf13dc-a009-027a-e053-2995a90a8ec8 | 2024-12-11 | Warnings | M022 |
| NATURAL LEMON MINT HERB THROAT DROPS | MENTHOL | Ricola USA Inc. | 763e8234-60be-4b1f-9f78-01c574f35d0a | 2024-12-10 | Warnings | M022 |
| Natural Cherry Honey Herb Throat Drops | MENTHOL | Ricola USA Inc. | 989f8509-cd28-48e7-9aa1-baddfbcac95a | 2024-12-10 | 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 |