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 |
|---|---|---|---|---|---|---|
| BABY MUCUS PLUS COLD RELIEF | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | d934cc8a-1e43-4942-858a-05b5d068679a | 2023-08-22 | Warnings | ETJ7Z6XBU4 |
| B HP | APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEA | Energique, Inc. | 8b1414d5-57d8-46d5-b4be-3011429bdd0d | 2023-08-21 | Warnings | ETJ7Z6XBU4 |
| Pituistat | ARALIA QUINQUEFOLIA, GINKGO BILOBA, ARSENICUM IODATUM, AVENA SATIVA, BARYTA CARBONICA, PHOSPHORUS, SILICEA, THYROIDINUM (SUIS), ALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUM | Energique, Inc. | 27a5fccb-8707-4bb5-a848-d1921bba2f7f | 2023-08-21 | Warnings | ETJ7Z6XBU4 |
| Cellergy | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA. | Ratis, LLC | 2aebc11e-eeb7-436b-b90c-3a2f59fb7492 | 2023-08-07 | Warnings | ETJ7Z6XBU4 |
| FLUORIDEX | SODIUM FLUORIDE | DENT-MAT HOLDINGS, LLC. | 6050ef4d-50e8-55d7-e053-2991aa0ad076 | 2023-08-03 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| MEB Puri-Mega | MEB PURI-MEGA | Kadesh Incoporation Co,Ltd | 018125f2-ad4b-b38a-e063-6294a90a7f6e | 2023-07-27 | Warnings | ETJ7Z6XBU4 |
| VACC HC | HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), 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. | c100d87b-4d67-42ef-b7e2-fd3642a104b8 | 2023-07-18 | Warnings | ETJ7Z6XBU4 |
| Denta 5000 Plus | SODIUM FLUORIDE | Rising Pharma Holdings, Inc. | 7142eb93-54ff-4ba1-af43-3fa3dc1fad01 | 2023-07-17 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR | BioActive Nutritional | 3382df85-3ec5-4371-830e-4ed345b8f51b | 2023-07-14 | Warnings | 368GB5141J |
| Silicea | SILICEA | Ratis, LLC | 8c2b59e1-9936-486c-9a91-153e46f377e6 | 2023-07-13 | Warnings | ETJ7Z6XBU4 |
| Pneumotox | TRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM, | BioActive Nutritional, Inc. | f8846fb1-92e5-4f8e-b3b3-bc620df90a62 | 2023-07-12 | Warnings | ETJ7Z6XBU4 368GB5141J |
| Silicea | SILICON DIOXIDE | Boiron | ce6a0710-7c28-11e6-86bf-424c58303031 | 2023-07-11 | ETJ7Z6XBU4 | |
| Tap Water Detox | ACETONE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARSENICUM METALLICUM, BARYTA MURIATICA, CADMIUM METALLICUM, CARBOLICUM ACIDUM, CHLORINUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, FERRUM METALLICUM, GERMANIUM METALLICUM, NATRUM FLUORATUM, PLUMBUM METALLICUM, RADIUM BROMATUM, VANADIUM METALLICUM, GLYPHOSATE HERBICIDE | Nutritional Specialties, Inc. | 37a48fea-a8df-4d27-b0c7-e5704c25e72f | 2023-07-11 | Warnings | 8ZYQ1474W7 |
| SODIUM PHENYLACETATE AND SODIUM BENZOATE | SODIUM PHENYLACETATE AND SODIUM BENZOATE | MAIA PHARMACEUTICALS, INC | 3529be10-0004-4628-9ca1-67a8acd86b51 | 2023-07-05 | Warnings, Adverse reactions | OJ245FE5EU |
| Kidney Drainage | SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM | Deseret Biologicals, Inc. | 4f82e261-6101-48ab-b161-ded5aa41cd85 | 2023-06-27 | Warnings | ETJ7Z6XBU4 |
| Calciforce | ARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICA | BioActive Nutritional, Inc. | 1609ce3e-82c2-4597-86e6-847c944ddbe6 | 2023-06-07 | Warnings | ETJ7Z6XBU4 |
| Silicea 6X | SILICEA 6X | True Botanica, LLC | fd296871-c491-7d30-e053-6294a90ab64d | 2023-06-02 | Warnings | ETJ7Z6XBU4 |
| Bacteriostatic Water | WATER | Medical Purchasing Solutions, LLC | 69485218-9343-952d-e053-2a91aa0ad4e8 | 2023-05-22 | Warnings, Adverse reactions | 059QF0KO0R |
| DentaGel | SODIUM FLUORIDE | Rising Pharma Holdings, Inc. | cda9e1f6-275d-43ba-9e30-f34094e80d95 | 2023-05-09 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Sterile Water | STERILE WATER | Hikma Pharmaceuticals USA Inc. | b20a28b0-7dfa-42eb-9177-ec256d5a5ef7 | 2023-05-08 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.