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
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 |
|---|---|---|---|---|---|---|
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | 584b38ce-d1ef-4ecc-a887-7c96e7f9669f | 2026-08-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Walgreens | fb93c7f6-e025-4cf2-9997-acfe9a0debdd | 2026-08-19 | Warnings | M022 |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | M022 |
| Ludens Honey Licorice Throat Drops | MENTHOL | Prestige Brands Holdings, Inc. | 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac | 2026-08-19 | Warnings | M022 |
| Ludens Dual Relief | PECTIN AND MENTHOL | Prestige Brands Holdings, Inc. | d0213cb3-ec8e-40cc-82c9-694032f0490f | 2026-08-19 | Warnings | M022 |
| CVS Health Sore Throat Fast Relief Oral Anesthetic | PHENOL | CVS Pharmacy,Inc. | 4fb880db-2185-41ef-a5f9-8983a28d2c5b | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Cherry | PHENOL | CVS Pharmacy,Inc. | 887c68e0-ff44-4bad-b360-56fb99ed9c45 | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Menthol Flavor | PHENOL | CVS PHARMACY,INC. | 665be058-b965-4b78-80b0-dd8524180932 | 2026-08-17 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Harris Teeter, LLC | 7e5f175d-f0d6-4665-ac14-1873d6b99c80 | 2026-08-12 | Warnings | M022 |
| Gingicaine Gel Variety Pak | GINGICAINE GEL VARIETY PAK | Gingi-Pak a Division of the Belport | 62ed4ff3-18f6-5c67-e053-2991aa0a7792 | 2026-08-11 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent ReadyInCase | HYDROGEN PEROXIDE | P & L Development, LLC | b0866db5-3b0d-4478-9b3b-1f077d2f5393 | 2026-08-06 | Warnings | M022 |
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 5868c5a1-273f-f023-e063-6394a90ac9d8 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58690bb5-9604-26a4-e063-6394a90afdbe | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586918cf-7b13-5999-e063-6294a90a88a9 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586924a0-322d-5dc3-e063-6294a90a1556 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58692e90-de74-52d3-e063-6394a90a9702 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586937ae-46af-7066-e063-6294a90ae53e | 2026-08-06 | Warnings | M022 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | 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 |