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 |
|---|---|---|---|---|---|---|
| CloSYS | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | ed617c7a-805c-4788-9bce-9b7fead4312d | 2026-03-31 | Warnings | M021 8ZYQ1474W7 |
| Lymphoplex | MYRRHA, TRIGONELLA FOENUM-GRAECUM, PINUS SYLVESTRIS, LYMPH (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRANGEA ARBORESCENS, PHYTOLACCA DECANDRA, SILICEA | BioActive Nutritional, Inc. | 624f35db-291e-4e7f-a2c9-ae319717157a | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Equisetum Silicea | EQUISETUM SILICEA | Uriel Pharmacy Inc. | e88b820b-4a07-42e2-8fe2-b30729e91a8c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| B Force HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA | BioActive Nutritional, Inc. | 811c6f32-fcad-464c-bcf6-ae6a59195b1c | 2026-03-30 | Warnings | ETJ7Z6XBU4 |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | 696cb342-fc5c-47cf-bbc8-5ecc706074c0 | 2026-03-27 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Lymphdrainex | GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA, | Energique, Inc. | c512f211-f4f8-46f6-87ed-dd50287359df | 2026-03-27 | Warnings | ETJ7Z6XBU4 |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | 0800f4ef-1d98-4c0f-a016-501791973f66 | 2026-03-27 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | 0f11c8c7-c73e-4610-83ed-e697539ac180 | 2026-03-27 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Tri-Vite Drops with Fluoride | ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | 15c78a03-17d7-43af-978f-1a64bd2240fe | 2026-03-27 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Colgate Total Enamel Strength | STANNOUS FLUORIDE | Colgate-Palmolive Company | 1f29c893-e7c5-4a0e-941b-c2634d821147 | 2026-03-25 | Warnings | M021 |
| AP-24 Whitening | SODIUM MONOFLUOROPHOSPHATE | NSE Products, Inc. | 57e9e68c-41dd-470b-80db-dfaedc0e2a0a | 2026-03-24 | Warnings | M021 |
| Kroger Extra Whitening | FLUORIDE | Kroger | e704c690-1383-4cd6-be85-28bdd9ff936b | 2026-03-24 | Warnings | 8ZYQ1474W7 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369c0d44-6375-dcae-e063-6394a90a74d0 | 2026-03-24 | Warnings | M021 8ZYQ1474W7 |
| Euthymol Whitening Purple Corrector | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369bc785-fb77-a56d-e063-6394a90a2e6b | 2026-03-24 | Warnings | M021 8ZYQ1474W7 |
| A plus Attention | BARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRA | NaturalCare | e77c2661-7ddf-4b09-b2e3-b9db3911011a | 2026-03-24 | Warnings | ETJ7Z6XBU4 |
| SensitiveToothpaste | ANTI SENSITIVETOOTHPASTE | Huain Best Trade Co., Ltd. | 4db239f3-2ad7-3a5b-e063-6294a90a11a7 | 2026-03-23 | Warnings | M021 |
| Nail Fungus Control | CALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDE | Forces of Nature | b7239e23-326e-4c1d-a080-55f457f1c454 | 2026-03-19 | Warnings | ETJ7Z6XBU4 |
| Sterile Water | WATER | Hospira, Inc. | 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828 | 2026-03-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | f28c8928-81c3-458a-9ce2-2aaca3b7527d | 2026-03-18 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Multivitamin with Fluoride | .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN D | Bryant Ranch Prepack | ef79cadb-c553-4af1-9a53-6ea1ab26b4bb | 2026-03-18 | Warnings, Adverse reactions | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.