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 |
|---|---|---|---|---|---|---|
| Sinus Tonic | ECHINACEA (ANGUSTIFOLIA), BAPTISIA TINCTORIA, THIAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, PYRIDOXINUM HYDROCHLORICUM, SPONGIA TOSTA, APIS MELLIFICA, ASCORBIC ACID, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LACHESIS MUTUS, MERCURIUS IODATUS RUBER, MERCURIUS SULPHURATUS RUBER, PULSATILLA (PRATENSIS), SILICEA, SINUSITISINUM, PANTOTHENIC ACID | BioActive Nutritional, Inc. | 63234fdc-7456-42c6-8996-fef372dd4a53 | 2025-05-20 | Warnings | ETJ7Z6XBU4 |
| Inflammation I | ECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEA | BioActive Nutritional, Inc. | ddfad5cd-c928-42c0-9562-9feebb73a2cb | 2025-05-19 | Warnings | ETJ7Z6XBU4 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 3582cc91-8c32-9f93-e063-6394a90a8792 | 2025-05-19 | Warnings | M021 8ZYQ1474W7 |
| EUTHYMOL WHITENING SET | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 35839b10-4c40-40e5-e063-6294a90a85b4 | 2025-05-19 | Warnings | M021 |
| Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry | FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 3573f149-2af9-4c86-e063-6294a90a7b3f | 2025-05-18 | Warnings | 8ZYQ1474W7 |
| Bubble Gum Flavor For Kids 25g 50g | BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 354c1eda-ec5b-a8c7-e063-6294a90a871d | 2025-05-16 | Warnings | 8ZYQ1474W7 |
| Vermex | ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM | BioActive Nutritional, Inc. | 06b61e15-ab8b-4b7e-8378-48f87a963e44 | 2025-05-16 | Warnings | ETJ7Z6XBU4 |
| Lymph II | ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA | BioActive Nutritional, Inc. | 678874d0-7600-4d03-ad1e-e4dc67157597 | 2025-05-16 | Warnings | ETJ7Z6XBU4 |
| SODIUM PHENYLACETATE and SODIUM BENZOATE | SODIUM PHENYLACETATE AND SODIUM BENZOATE | Omnivium Pharmaceuticals LLC | 8fafc39b-69db-40f3-8a09-ee859e8cef19 | 2025-05-15 | Warnings, Adverse reactions | OJ245FE5EU |
| Vax Sode | THUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITIS | Nutritional Specialties, Inc. | 6f8cfcad-4d23-44d3-9369-22b575b1e7e6 | 2025-05-15 | Warnings | ETJ7Z6XBU4 |
| Apnetem | PHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME A | Nucleic Products, LLC | ec5bc7e7-4be6-45a6-8cd9-62fdfa7fb469 | 2025-05-14 | Warnings | ETJ7Z6XBU4 |
| Eyesaline Emergency Eyewash | STERILE EYESALINE EYEWASH | Honeywell Safety Products USA, Inc. | 2d567518-4c54-7448-e063-6294a90a3e64 | 2025-05-14 | Warnings | 059QF0KO0R |
| Hello Unicorn Sparkle | SODIUM FLUORIDE | Colgate-Palmolive Company | 5acfbd9b-278c-24dd-8041-5e2cdffbf710 | 2025-05-13 | Warnings | M021 8ZYQ1474W7 |
| Optimax Anticavity Fluoride Cotton Candy | SODIUM MONOFLUOROPHOSPHATE | WHITE GLO USA INC | 25f182cb-ad1e-4c13-bc79-1ec251754cf8 | 2025-05-12 | Warnings | M021 |
| Optimax Anticavity Fluoride Watermelon | SODIUM MONOFLUOROPHOSPHATE | WHITE GLO USA INC | b506df13-649f-4615-bc25-6ae08bd56b18 | 2025-05-12 | Warnings | M021 |
| Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint | SODIUM FLUORIDE | Kenvue Brands LLC | 346daeae-7590-176c-e063-6294a90a52ea | 2025-05-05 | Warnings | M021 8ZYQ1474W7 |
| Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash | SODIUM FLUORIDE | Kingkey MBC Life Technology Group co., LTD. | 3de0d71a-7704-97dd-e063-6294a90a5d2c | 2025-05-01 | Warnings | M021 8ZYQ1474W7 |
| Brush Buddies Value 2 pack Whitening | SODIUM MONOFLUOROPHOSPHATE | Ashtel Studios, Inc | 636bf51d-9750-4305-ab4a-3483c9f0169b | 2025-04-30 | Warnings | M021 |
| Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope | SODIUM FLUORIDE | Navajo Manufacturing Company Inc | 3adb1524-0fd6-4728-b757-dcbda4cdd0fb | 2025-04-29 | Warnings | M021 8ZYQ1474W7 |
| DOCTRUST ONE S Tooth | SODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATE | DOCSMEDI Co., Ltd. | 3382776a-a10e-1823-e063-6394a90a6f91 | 2025-04-24 | Warnings | 8ZYQ1474W7 ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.