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 |
|---|---|---|---|---|---|---|
| Moon Charcoal Whitening Anticavity | SODIUM FLUORIDE | Moon Oral Care, LLC | 0c55f7b3-fea1-58f3-e063-6394a90a3bde | 2023-12-12 | Warnings | M022 |
| ORCA Complete Menthol Pain Reliever | MENTHOL | ORCA Products, LLC | 99990e27-d66b-4d61-97f2-6a76066eb8b8 | 2023-12-08 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 0070858b-e02e-431f-a7c2-313fef01791b | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | d1802f08-80cb-41dd-b34d-9c576b101ddb | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 80182c43-100f-4b15-a07e-819599ab9562 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | c19e6426-8f1e-47b3-a3a6-551a5bec6cd9 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 1f8431bb-f33c-4fd8-9472-9b59ffb5f18e | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 1163d248-d648-443e-bed0-ccb7fd26ba63 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 88caabe2-a096-44d0-98d3-afad1935c012 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | c1b02a2f-db1f-44f0-a74a-d02c085c5bd7 | 2023-12-07 | Warnings | M022 |
| Gelato Topical Anesthetic | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 39081585-fe6a-4ba1-93f8-d92d26fe75bc | 2023-12-07 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | d7c69357-795c-03d8-e053-2a95a90a03a6 | 2023-12-06 | Warnings | M022 |
| Dr. Sheffield Sensitive Care | SENSITIVE TOOTH PASTE | Sheffield Pharmaceuticals LLC | 702a0dec-64cf-4834-8d80-f3d4f0c08a3a | 2023-11-30 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | f3bf106c-5320-ced2-e053-2a95a90a71ac | 2023-11-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0b517321-25ed-2676-e063-6294a90ab4c9 | 2023-11-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0b51b67c-03ac-5730-e063-6394a90a5060 | 2023-11-29 | Warnings | M022 |
| Pearl White | POTASSIUM NITRATE, SODIUM FLUORIDE | Beyond International Inc. | 51c79544-9536-5863-e054-00144ff8d46c | 2023-11-28 | Warnings | M022 |
| UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE | POTASSIUM NITRATE AND SODIUM FLUORIDE | Universal Distribution Center LLC | fcf59439-7e06-4129-a89f-cdeecdf8d488 | 2023-11-17 | Warnings | M022 |
| PerioRestore | HYDROGEN PEROXIDE | DEN-MAT HOLDINGS, LLC. | 97a07c36-1af8-a636-e053-2a95a90ad6db | 2023-11-13 | Warnings | M022 |
| Wild Horse 777 Oral | PHENOL | Wild Horse 777, Inc. | b0b517bb-969f-0c65-e053-2995a90a48b1 | 2023-11-10 | 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 |