NDC 65517-2004-01 - DawnMist Gel Fluoride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 65517-2004
- Requested NDC
- 65517-2004-01
- Package NDCs from labels
- 65517-2004-1, 65517-2004-0, 65517-2004-2, 65517-2004-3, 65517-2004-01
- Manufacturer
- Dukal LLC
- Effective date
- 2025-02-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| DawnMist Gel Fluoride - Dukal LLC | Dukal LLC | 2025-02-07 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65517-2004-0 | DawnMist Gel Fluoride | 78 g in 1 TUBE | GEL, DENTIFRICE | 78 | 3 | |
| 65517-2004-1 | DawnMist Gel Fluoride | 17 g in 1 TUBE | GEL, DENTIFRICE | 17 | 3 | |
| 65517-2004-2 | DawnMist Gel Fluoride | 24 g in 1 TUBE | GEL, DENTIFRICE | 24 | 3 | |
| 65517-2004-3 | DawnMist Gel Fluoride | 43 g in 1 TUBE | GEL, DENTIFRICE | 43 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65517-2004 | DAWNMIST GEL FLUORIDE (GEL FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [DUKAL LLC] | 3 | Current NDC, 4 package rows | 20250210_14443184-1694-70b9-e063-6394a90a86fe.zip |
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 |
|---|---|---|---|---|---|---|
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | 8ZYQ1474W7 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | Warnings | 8ZYQ1474W7 |
| Freshness Coffee Toothpaste100g | FRESHNESS COFFEE TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d79e9-2f0f-fa72-e063-6394a90a8dea | 2026-08-06 | Warnings | 8ZYQ1474W7 |
| Freshness Flower Rose Toothpaste100g | FRESHNESS FLOWER ROSE TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d7f5e-55e0-4fd2-e063-6294a90a92b6 | 2026-08-06 | Warnings | 8ZYQ1474W7 |
| Colgate Optic White Stain Fighter With Baking Soda | SODIUM FLUORIDE | Colgate-Palmolive Company | 8e6113e2-101b-4bde-90e9-6ab32c6ebf5c | 2026-08-05 | Warnings | M021 8ZYQ1474W7 |
| COLGATE MAX FRESH WATERMELON BLAST | SODIUM FLUORIDE | Colgate-Palmolive Company | 6c391ef3-d625-403c-a4dc-6e2212682ed1 | 2026-08-04 | Warnings | M021 8ZYQ1474W7 |
| ROROBELL WAWA Whitening Tooth | SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE | ROROBELL | 58336a0d-49dd-ef13-e063-6394a90a38c1 | 2026-08-04 | Warnings | ETJ7Z6XBU4 |
| ROROBELL WAWA Sensitive Teeth Tooth | HYDRATED SILICA, POTASSIUM NITRATE, SODIUM FLUORIDE | ROROBELL | 58344745-544b-5f24-e063-6294a90ad5a7 | 2026-08-04 | Warnings | 8ZYQ1474W7 |
| Silicea 6X | SILICON DIOXIDE | Hyland's Inc. | db4be3c1-aa7e-24a2-e053-2a95a90a0c66 | 2026-08-04 | Warnings | ETJ7Z6XBU4 |
| Rorobell WaWa Tooth | SODIUM MONOFLUOROPHOSPHATE | ROROBELL | 93113481-ad9d-4be0-a7b7-a72c8726127d | 2026-08-03 | Warnings | M021 |
| ROROBELL WAWA Gum Care Tooth | HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE | ROROBELL | 582204ef-b784-0d95-e063-6394a90a38d2 | 2026-08-03 | Warnings | 8ZYQ1474W7 |
| Smogstat | ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA | Energique, Inc. | 59f63e2b-24fa-43a0-8334-02e6729c6ac1 | 2026-07-31 | Warnings | ETJ7Z6XBU4 |
| Garzulys | INSULIN ASPART-FSAN | Meitheal Pharmaceuticals Inc. | 30c64769-d2f7-4604-ac9e-2a6bc09506c9 | 2026-07-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Muscle Ice | PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS) | Peaceful Mountain, Inc. | 03b6e2a9-f335-4ae2-9011-80bd019afb72 | 2026-07-30 | Warnings | ETJ7Z6XBU4 |
| Bioplasma | SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE | Hyland's Inc. | dd0a7ed2-d112-4b96-e053-2995a90ac6b6 | 2026-07-30 | Warnings | ETJ7Z6XBU4 |
| COLGATE OPTIC WHITE CHARCOAL | SODIUM FLUORIDE | Colgate-Palmolive Company | 70ed4a93-b68f-4198-b4b7-7cfeb17ba5d2 | 2026-07-30 | Warnings | M021 8ZYQ1474W7 |
| Colgate Optic White Charcoal | SODIUM FLUORIDE | Colgate-Palmolive Company | 82ac5b9d-19e8-46ac-a195-c7d85f2967d5 | 2026-07-30 | Warnings | M021 8ZYQ1474W7 |
| Supersmile Professional Whitening TP Peppy Mint 1.4 oz | SODIUM MONOFLUOROPHOSPHATE | Robell Research, Inc | 251264ea-20d2-be19-e063-6394a90aa5f6 | 2026-07-29 | Warnings | M021 |
| Natural White Sensitive Enamel Guard Alpine Mint | SODIUM FLUORIDE | Lornamead Products | 2e832204-ba2d-6dcb-e063-6394a90a5e6c | 2026-07-29 | Warnings | M021 8ZYQ1474W7 |
| Lornamead Natural White | FLUORIDE | Lornamead Products | 9d7d08d7-8ca4-4b05-8b74-3bfa372b1608 | 2026-07-29 | Warnings | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.