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 |
|---|---|---|---|---|---|---|
| Denta 5000 Plus Sensitive | SODIUM FLUORIDE AND POTASSIUM NITRATE | Rising Pharma Holdings, Inc. | 585fb1f5-8c08-43bd-8be4-64adc065d9a2 | 2023-11-09 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| EUTHYMOL Extraordinary Pink Whitening | SODIUM FLUORIDE | LG H&H CO., LTD. | 0989936c-237d-dc63-e063-6294a90a885f | 2023-11-07 | Warnings | M021 8ZYQ1474W7 |
| CV TOX | COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODE | BioActive Nutritional, Inc. | 8ef2fb5c-1b24-46a1-8d21-a78ce0a34a87 | 2023-11-07 | Warnings | ETJ7Z6XBU4 |
| Eurofresh Whitening | SODIUM FLUORIDE | Farmasi US LLC | b56b2b55-e3a4-785a-e053-2a95a90a7abf | 2023-11-05 | Warnings | M021 8ZYQ1474W7 |
| Farmasi Whitening | SODIUM FLUORIDE | Farmasi US LLC | 25b3608e-abed-41ca-9971-21981b8a4610 | 2023-11-05 | Warnings | M021 8ZYQ1474W7 |
| Leg Cramps-Swelling | ECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPS | Newton Laboratories, Inc. | 9c31d465-caac-3a02-e053-2a95a90adb3b | 2023-11-03 | Warnings | ETJ7Z6XBU4 |
| Thymus Sarcode | ECHINACEA PURPUREA, MYRISTICA SEBIFERA, BELLADONNA, CALCAREA SULPHURICA, THYMUS (OVINE), ARSENICUM ALBUM, SILICEA, SULPHUR IODATUM, CALCAREA FLUORICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS | Nutritional Specialties, Inc. | 2dfda48f-5795-4b98-8bb2-bf65273e8920 | 2023-11-01 | Warnings | ETJ7Z6XBU4 |
| Mineffect skin protectant | ALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM | Kadesh Incoporation Co,Ltd | 84a86989-bb7c-4f96-8cc0-d67626484532 | 2023-10-31 | Warnings | ETJ7Z6XBU4 |
| Mineffect nasal mist | CALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM, | Kadesh Incoporation Co,Ltd | 3a29bf95-a8a3-4517-aedf-0cd4a91b349c | 2023-10-31 | Warnings | ETJ7Z6XBU4 |
| Mineffect acid indigestion and heartburn relief | ALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, MAGNESIA MURIATICA, NATRUM NITRICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM | Kadesh Incoporation Co,Ltd | 048367ff-a9bb-46a3-a835-aa3ab391eee4 | 2023-10-31 | Warnings | ETJ7Z6XBU4 |
| Mineffect hangover relief | ALUMINA SILICATA, CALCAREA SILICATA, SILICEA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, FERRUM MURIATICUM, SULPHUR, PHOSPHORUS | Kadesh Incoporation Co,Ltd | c9821e87-1e8d-48ab-8821-32e7e660309a | 2023-10-31 | Warnings | ETJ7Z6XBU4 |
| Mineffect first aid antiseptic and antibiotic solution | SILICEA, SULPHUR, PHOSPHORUS, CALCAREA SILICATA, NATRUM NITRICUM, FERRUM MURIATICUM, KALI SILICATUM | Kadesh Incoporation Co,Ltd | 9bd266bb-7078-413f-8fc9-642353589130 | 2023-10-31 | Warnings | ETJ7Z6XBU4 |
| Mineffect cold remedy | CALCAREA FLOURICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, SILICEA, SULPHUR, ZINCUM METALLICUM | Kadesh Incoporation Co,Ltd | 14d2a1fe-a1f1-4e85-96c0-d8b90260336c | 2023-10-31 | Warnings | ETJ7Z6XBU4 |
| Sodium phenylacetate and Sodium benzoate | SODIUM PHENYLACETATE AND SODIUM BENZOATE | Zydus Pharmaceuticals USA Inc. | 0f17c50f-3761-4470-bf3b-63837a287b8a | 2023-10-30 | Warnings, Adverse reactions | OJ245FE5EU |
| United Airlines Therabody UPP Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | fb6c355b-a67d-c4b4-e053-6394a90a0e66 | 2023-10-26 | Warnings | M021 |
| United Dental Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | 7f348fe7-9918-4934-bed0-f0a77c09d046 | 2023-10-26 | Warnings | M021 |
| United Airlines Therabody Polaris Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | ab667740-55ab-470e-9514-163961502ceb | 2023-10-26 | Warnings | M021 |
| Cavity Protection Fresh Mint | SODIUM FLUORIDE | Oxyfresh Worldwide Inc | 0ae98f28-7e78-4379-93b0-4f2657415c4d | 2023-10-25 | Warnings | M021 8ZYQ1474W7 |
| Tanners Tasty Vanilla Bling | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 521fe01e-7f2e-4d79-9126-e4880cdf4e71 | 2023-10-24 | Warnings | M021 8ZYQ1474W7 |
| Tanners Tasty Ooh La La Orange | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 6027b961-314e-4f71-8b2f-646ce80214d8 | 2023-10-24 | Warnings | M021 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.