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 |
|---|---|---|---|---|---|---|
| Dentalclean Booster Kids | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 186ecaeb-9401-9315-e063-6394a90a8e20 | 2024-05-14 | Warnings | M021 8ZYQ1474W7 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE | 9055-7588 Qubec Inc. DBA ATTITUDE | fefc1060-e1a4-4686-a8d8-84bf1e613abe | 2024-05-14 | Warnings | M021 8ZYQ1474W7 |
| Dentalclean Doctor Duck | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 186f2f12-279f-32df-e063-6394a90ad53d | 2024-05-14 | Warnings | M021 8ZYQ1474W7 |
| sensodyne | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 16225f06-1d40-416a-aaec-7890e398fe4b | 2024-05-13 | Warnings | 8ZYQ1474W7 |
| Aging Eye Formula | CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM | Nutritional Specialties, Inc. | 4510fe59-cc28-4585-925f-42508a60abd0 | 2024-05-13 | Warnings | ETJ7Z6XBU4 |
| Sodium Phenylacetate and Sodium Benzoate | SODIUM PHENYLACETATE AND SODIUM BENZOATE | FOSUN PHARMA USA INC | cee1e9a2-bbe5-2419-e053-2a95a90ac3ef | 2024-05-09 | Warnings, Adverse reactions | OJ245FE5EU |
| EMF Protect and Balance | ALFALFA, FUCUS VESICULOSUS, KALI PHOSPHORICUM, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, FERRUM METALLICUM, CADMIUM SULPHURATUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, MERCURIUS VIVUS, PLUMBUM METALLICUM, YTTERBIUM OXIDE, TARENTULA CUBENSIS, X-RAY, CUPRUM METALLICUM, SILICEA | Deseret Biologicals, Inc. | df7e925e-00d1-4b0c-8a78-ad38148bc360 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Multiple Miasm | ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, SULPHUR, ALOE, CARCINOSIN, NITRICUM ACIDUM, SILICEA, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 0cf54ec3-d731-4f27-89fd-4571d991a615 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Osteopar | EQUISETUM HYEMALE, SYMPHYTUM OFFICINALE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, MEDULLA OSSIS SUIS, OSSA SEPIA, SILICEA, HEKLA LAVA | Energique, Inc. | daf83dbf-bbf4-49e2-ade1-1d86f3e52675 | 2024-05-09 | Warnings | ETJ7Z6XBU4 |
| Dentalclean Regenerator Sensitive Kids | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17f31b5e-dd3b-78df-e063-6294a90a43ab | 2024-05-08 | Warnings | M021 8ZYQ1474W7 |
| Dentalclean Dental Gel Booster Adult Use | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17f3981f-ab4b-0dcd-e063-6294a90a37d9 | 2024-05-08 | Warnings | M021 8ZYQ1474W7 |
| Occuloplex I | EUPHRASIA OFFICINALIS, GINKGO BILOBA, TARAXACUM OFFICINALE, HYDRASTIS CANADENSIS, GLUTATHIONE, UBIDECARENONUM, ZINCUM GLUCONICUM, CITRUS BIOFLAVONOIDS, EYE (SUIS), AMMONIUM MURIATICUM, CALCAREA FLUORICA, CAUSTICUM, CONIUM MACULATUM, CYANOCOBALAMIN, GERMANIUM SESQUIOXIDE, MAGNESIA CARBONICA, SELENIUM DIOXIDE, SILICEA, BETA CAROTENE | BioActive Nutritional, Inc. | c2c9b577-4f75-4ddc-815f-46c3bb9b46d2 | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| Lymphoplus | TRIFOLIUM PRATENSE, LYMPH NODE (SUIS), SPLEEN (SUIS), CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), LYCOPODIUM CLAVATUM, MYRRHA, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA | Deseret Biologicals, Inc. | 92f6fc6b-58c0-4137-88b3-bee2118aeb29 | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | a1b42f4b-4029-4008-b950-a7725f34b43d | 2024-05-08 | Warnings | ETJ7Z6XBU4 |
| Dentalclean Sensitive Plus | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17e0dc93-97bf-7f05-e063-6294a90a9a8b | 2024-05-07 | Warnings | M021 8ZYQ1474W7 |
| Dentalclean Whitening Max | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 17e2364e-2511-3021-e063-6294a90a40e1 | 2024-05-07 | Warnings | M021 8ZYQ1474W7 |
| DeCure | SODIUM MONOFLUOROPHOSPHATE | Scope medical devices private limited | 590c4827-f036-45bd-af30-0a4853ca3447 | 2024-05-07 | Warnings | M021 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | 04dfad30-9496-43c6-8ce8-ab04fdb9ce3b | 2024-05-06 | Warnings | ETJ7Z6XBU4 |
| Enviroclenz | BERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM | Deseret Biologicals, Inc. | 92816bbe-96d6-45fc-9929-d3e6df394a33 | 2024-05-02 | Warnings | 368GB5141J |
| AI Miasm | ASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUM | Energique, Inc. | df829e4a-c982-4d02-b318-38b1fbc5072d | 2024-05-02 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.