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 |
|---|---|---|---|---|---|---|
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE AND POTASSIUM NITRATE | 9055-7588 Quebec Inc. DBA Attitude | 42b79ec5-f37f-4dc9-9631-c8b1c153fe88 | 2024-04-26 | Warnings | 8ZYQ1474W7 |
| VACC HC | HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM | Deseret Biologicals, Inc. | a98082ba-21ec-4cf8-b81c-bcb41eb9fd12 | 2024-04-23 | Warnings | ETJ7Z6XBU4 |
| PEMF Optimizer | AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 97d57469-4c5b-4d3f-9398-3a1a6617a649 | 2024-04-23 | Warnings | 059QF0KO0R |
| Gelato Homecare | STANNOUS FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf | 2024-04-22 | Warnings | M021 |
| Gelato Neutral pH | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 281fe774-91e1-403f-b58a-92bcc09292ab | 2024-04-22 | Warnings | 8ZYQ1474W7 |
| Gelato Neutral pH | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 2dda92cc-2e50-4fa8-a214-714750943b00 | 2024-04-22 | Warnings | 8ZYQ1474W7 |
| Gelato Neutral pH | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 738c98a9-6549-4179-8758-fc026c61c372 | 2024-04-22 | Warnings | 8ZYQ1474W7 |
| Gelato Neutral pH | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | 2f8fe488-4a1b-451a-852b-4ddc2cf08347 | 2024-04-22 | Warnings | 8ZYQ1474W7 |
| Ligapar | LAPPA MAJOR, LIGAMENT (HUMAN), CARTILAGO SUIS, ARNICA MONTANA, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CAUSTICUM, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SILICEA, ZINCUM METALLICUM | Energique, Inc. | 17f6b1f5-8e49-49df-bad4-9c19fa677e69 | 2024-04-22 | Warnings | ETJ7Z6XBU4 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 27a7905a-110e-46ce-803d-9c75a530c838 | 2024-04-19 | Warnings | 8ZYQ1474W7 |
| Gelato Homecare | STANNOUS FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db | 2024-04-19 | Warnings | M021 |
| Visiopar | EUPHRASIA OFFICINALIS, EYE (SUIS), AURUM METALLICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, MAGNESIA CARBONICA, PHOSPHORUS, SILICEA, PHYSOSTIGMA VENENOSUM, OSMIUM METALLICUM, THUJA OCCIDENTALIS | Energique, Inc. | 811f7626-0d21-49bd-8c31-9a5abec45c13 | 2024-04-19 | Warnings | ETJ7Z6XBU4 |
| EVTOX | COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE | BioActive Nutritional, Inc. | 4b518e10-9ce0-492b-92be-6025d8d7c3c6 | 2024-04-19 | Warnings | ETJ7Z6XBU4 |
| Sodium Fluoride and Potassium Nitrate | SODIUM FLUORIDE AND POTASSIUM NITRATE | Westminster Pharmaceuticals, LLC | 7a051d80-879d-4995-96ef-77b60dad26b7 | 2024-04-18 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Sterile Water | WATER | Hikma Pharmaceuticals USA Inc. | 78ef7ad3-451d-43d0-a9b6-5cf0aadca003 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8fc8d87a-3951-4ac5-97df-c161ffc90475 | 2024-04-10 | Warnings, Adverse reactions | 059QF0KO0R |
| Toothpaste, plus Toothbrush | SODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSH | Lil' Drug Store Products, Inc. | 15ac00f8-da51-6cea-e063-6294a90aeb81 | 2024-04-09 | Warnings | M021 |
| Aquafresh Extreme Clean Pure Breath Action | SODIUM FLUORIDE | Haleon US Holdings LLC | 462eb309-deca-4464-b13a-7ae314e53ede | 2024-04-08 | Warnings | 8ZYQ1474W7 |
| VAXR HC | THUJA OCCIDENTALIS, MEZEREUM, SILICEA, CALCAREA CARBONICA, MORBILLINUM, PAROTIDINUM, PERTUSSINUM, RUBELLA NOSODE, TETANUS TOXIN, CARCINOSIN, ANTIMONIUM CRUDUM, LEDUM PALUSTRE, THIMEROSAL, POLIOMYELITIS NOSODE | Deseret Biologicals, Inc. | fdf8d21a-2ae1-4842-abf3-737841995939 | 2024-04-03 | Warnings | ETJ7Z6XBU4 |
| Eye Wash | WATER | M-star (Hubei) Health&Care Products Co., Ltd. | 71706039-e250-4f08-9687-71b2928c4e46 | 2024-04-01 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.