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 |
|---|---|---|---|---|---|---|
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, UBIDECARENONUM, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, MELATONIN, PYRROLE, TRYPTOPHAN, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS | Deseret Biologicals, Inc. | f267fff4-f331-49b8-bd48-7d383da52246 | 2023-01-11 | Warnings | ETJ7Z6XBU4 |
| DALEKTRO N | SILVER NITRATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COBALTOUS NITRATE HEXAHYDRATE, CUPRIC ACETATE, IRON, POTASSIUM CARBONATE, MAGNESIUM CHLORIDE, MANGANESE ACETATE TETRAHYDRATE, SELENIUM, SILICON DIOXIDE, AND ZINC PHOSPHIDE | PEKANA Natruheilmittel GmbH | 2b39ce30-54ff-4586-bda1-d9410140b26e | 2023-01-11 | Warnings | ETJ7Z6XBU4 |
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | 059QF0KO0R ETJ7Z6XBU4 |
| ChemDetox | BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM | Dr. Donna Restivo DC | 2a17f80d-12c0-43a0-980b-9da648e9b76a | 2023-01-10 | Warnings | 506T60A25R |
| ZOOBY Growlin Grrrape | SODIUM FLUORIDE | Young Dental Manufacturing Co 1, LLC | fcebb175-d412-4452-9c7c-a38571006bfc | 2023-01-03 | Warnings | 8ZYQ1474W7 |
| ZOOBY Gator Gum | SODIUM FLUORIDE | Young Dental Manufacturing Co 1, LLC | c257d280-8cf3-43e4-b7b7-0a46f493d5b6 | 2023-01-03 | Warnings | 8ZYQ1474W7 |
| ZOOBY Spearmint Safari | SODIUM FLUORIDE | Young Dental Manufacturing Co 1, LLC | bd49f704-4fc4-42a3-aa87-2b41d15d86bb | 2023-01-03 | Warnings | 8ZYQ1474W7 |
| ZOOBY Happy Hippo Cake | SODIUM FLUORIDE | Young Dental Manufacturing Co 1, LLC | da461cb0-430d-458a-98c0-f713e8d51ddd | 2023-01-03 | Warnings | 8ZYQ1474W7 |
| ZOOBY Turtle Melon | SODIUM FLUORIDE | Young Dental Manufacturing Co 1, LLC | 1dd2d298-ea9a-44d3-85c2-0c000834e794 | 2023-01-03 | Warnings | 8ZYQ1474W7 |
| SUPREN | ARSENIC TRIOXIDE, SULFURIC ACID, CHAMAELIRIUM LUTEUM ROOT, GOLDENSEAL, WOOD CREOSOTE, LEMNA MINOR, MAGNESIUM FLUORIDE, AND SILICON DIOXIDE | PEKANA Naturheilmittel GmbH | 3b34740c-b181-4f05-9858-15b7211a4c67 | 2022-12-22 | Warnings | ETJ7Z6XBU4 |
| KELAN | SILICON DIOXIDE, ARNICA MONTANA ROOT, GRAPHITE, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, MAGNESIUM FLUORIDE, MAGNESIUM SULFATE HEPTAHYDRATE, AND RUTA GRAVEOLENS FLOWERING TOP | PEKANA Naturheilmittel GmbH | 55786d99-ee1f-490f-9023-3e6c39da86b0 | 2022-12-22 | Warnings | ETJ7Z6XBU4 |
| COLIC CP | AETHUSA CYNAPIUM, ALUMINUM OXIDE, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE CRUDE, MATRICARIA RECUTITA, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR. | Natural Creations, Inc. | 7c2a2f6e-a332-4c68-a7a8-fdc390f1827e | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0315c9e-8922-c0b5-e053-2a95a90ae54e | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f031e256-fca5-3939-e053-2995a90a4fe6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| SILICEA | SILICON DIOXIDE | Hyland's Inc. | 86da31ff-b39a-4ac2-92e5-810f6d8888e6 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f0328097-e5d2-3532-e053-2a95a90a93f0 | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Warts | ANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUM | Newton Laboratories, Inc. | f032e7bb-a6fd-2951-e053-2a95a90a8c3a | 2022-12-19 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICON DIOXIDE | Hyland's Inc. | d3c426ab-1a61-3494-e053-2a95a90a9677 | 2022-12-14 | Warnings | ETJ7Z6XBU4 |
| Silicea | SILICEA | Hahnemann Laboratories, INC. | efcdc393-5dab-38d1-e053-2995a90acb2e | 2022-12-14 | ETJ7Z6XBU4 | |
| Defend Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PATENS, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | bb851be1-0528-4199-91e7-e09f994b2862 | 2022-12-12 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.