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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | WinCo Foods, LLC | 9417b340-942b-48bf-bbfd-4cd5154082b9 | 2025-02-12 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | b291811f-8fac-45e2-a9a2-b3ecc0813d0d | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | fea30599-5e3b-4163-9660-d41b3fcee143 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 3be68966-199c-481e-8b9e-e994c41fd96a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | ccdee0cc-2bc9-4165-a411-02f4f900d86a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b7 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 69c4dd1b-a0db-4495-bfc3-faffdfdf59bf | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | d5ef3e65-35e8-4323-9f33-3076b561e105 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 746df21c-e92e-4a71-b1c6-baf99785a43e | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 2345e614-c7b6-448c-8e07-31700bade91c | 2025-01-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Belport Company, Inc. DBA Gingi-Pak | 142062ca-6f8f-78d2-e063-6294a90a19d8 | 2025-01-29 | Warnings, Adverse reactions | M022 |
| CHLORASEPTIC MAX | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | edd12a2d-aa27-4f15-9ce6-862e4b6144c4 | 2025-01-23 | Warnings | M022 |
| meijer Sensitive FRESH MINT | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | bea36d55-1a5d-40c0-b422-92fb36043ee6 | 2025-01-23 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 159d412c-6d1a-45d4-88c0-8c93960f946e | 2025-01-21 | Warnings | M022 |
| SEACALL Mouthwash | MOUTHWASH | Guangdong Quadrant Ecological Technology Co., Ltd. | 2c1a7eed-6a7c-eeb2-e063-6394a90aafcc | 2025-01-19 | Warnings | M022 |
| BENZOCAINE Raspberry | BENZOCAINE | Darby Dental Supply, LLC | dd805400-26c5-4c18-ade2-821298233f9b | 2025-01-17 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | c68fd8c7-7ec3-cc3f-e053-2995a90a4395 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | d22f7776-1b3c-4744-bcfe-8d9597218d73 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9c6a26e8-1253-49f7-9ce2-45c0d39f05c5 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 48178733-7433-41ec-b178-1314e0edab1a | 2025-01-16 | 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 |