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 |
|---|---|---|---|---|---|---|
| MIPaste One Kids Cotton Candy | MIPASTE ONE KIDS COTTON CANDY | GC America Inc. | c07d6b50-1d67-ea7f-e053-2a95a90afbe4 | 2025-12-19 | Warnings | M021 8ZYQ1474W7 |
| MIPaste One Kids Bubble Gum | MIPASTE ONE KIDS BUBBLE GUM | GC America Inc. | c07c7853-763b-4383-e053-2995a90ab725 | 2025-12-19 | Warnings | M021 8ZYQ1474W7 |
| MIPaste One | MIPASTE ONE | GC America Inc. | d71f8e6e-7005-4b3e-e053-2995a90a6789 | 2025-12-19 | Warnings | M021 8ZYQ1474W7 |
| Somineze | HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEA | BioActive Nutritional, Inc. | c0f80b84-0dd5-416b-abdf-8a0412e0b40b | 2025-12-18 | Warnings | ETJ7Z6XBU4 |
| Sterile Water | WATER | ProPharma Distribution | 386a0a2f-4ff7-f128-e063-6294a90a7d4d | 2025-12-18 | Warnings, Adverse reactions | 059QF0KO0R |
| Hepatatox | TRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUM | BioActive Nutritional, Inc | a113a9f1-4792-41a5-8d1b-a6756f356e15 | 2025-12-18 | Warnings | 506T60A25R |
| Vaccine Support CP | BELLADONNA, CALCAREA CARBONICA, CARCINOSINUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MALANDRINUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PYROGENIUM, SARSAPARILLA, SILICEA, SULPHUR, THUJA OCCIDENTALIS | Natural Creations, Inc | b99f6b65-fe22-4dc2-97f8-8ab315396f75 | 2025-12-18 | Warnings | ETJ7Z6XBU4 |
| SCROPHULOUS HP | BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEA | BioActive Nutritional, Inc. | 3421f76b-bcde-42b5-a04b-05099520e661 | 2025-12-18 | Warnings | ETJ7Z6XBU4 |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM | Energetix Corporation | 9b532a31-530a-44f9-843f-f395a3e460b8 | 2025-12-17 | Warnings | ETJ7Z6XBU4 |
| LEG CRAMPS PM | OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR | Walgreen Company | d8c7ec58-5453-0e58-e053-2995a90abff1 | 2025-12-17 | Warnings | ETJ7Z6XBU4 |
| Pan-Zyme-S | PANCREAS BALANCE | Vitality Works, Inc. | 4f6e18ca-719c-445e-9dad-fc40ad9e1aeb | 2025-12-17 | Warnings | ETJ7Z6XBU4 |
| RPT-Sys | EMOTIONAL REBALANCE | Vitality Works, Inc. | 0e8768fe-c2ba-41e9-93ac-c142fae6e879 | 2025-12-17 | Warnings | ETJ7Z6XBU4 |
| DigestivEase | ARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEA | Eight and Company L.L.C | 70840ff7-75c0-44a0-9eb8-b36f13518af2 | 2025-12-17 | Warnings | ETJ7Z6XBU4 |
| TheraBreath AM-PM Twin Pack | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4618e390-9039-a1d0-e063-6294a90ab294 | 2025-12-16 | Warnings | M021 |
| Mold Antigen | ALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCC | Natural Creations, Inc | 9dd6f22e-45b0-4771-80f7-6f530c96350d | 2025-12-16 | Warnings | ETJ7Z6XBU4 |
| Scar | CALENDULA, GRAPHITES, HYPERICUM PERFORATUM, STAPHYSAGRIA, SILICEA, THIOSINAMINUM | Natural Creations, Inc | f83f2234-24dc-4fb9-972e-ada049d940ed | 2025-12-16 | Warnings | ETJ7Z6XBU4 |
| SCROPHULOUS HP | BARIUM CARBONATE, BROMINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, FERROUS IODIDE, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE | Natural Creations, Inc. | fb30a5cf-7d25-48f3-a6e6-0cc4c1f41892 | 2025-12-16 | Warnings | ETJ7Z6XBU4 |
| INJURY HP | ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, SILICON DIOXIDE, DELPHINIUM STAPHISAGRIA SEED, COMFREY ROOT | Natural Creations, Inc. | 10be3e95-da2f-4340-8c12-2e676472a94d | 2025-12-16 | Warnings | ETJ7Z6XBU4 |
| SINUS HP | AMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIG | Natural Creations, Inc. | f017da22-74c2-40f4-adcc-5e84b6ea5291 | 2025-12-16 | Warnings | ETJ7Z6XBU4 |
| Respirasode | BRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDIS | Natural Creations, Inc | ce06327f-7e5e-420a-9b61-0d410f9e10d6 | 2025-12-16 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.