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 |
|---|---|---|---|---|---|---|
| Mammaryplex | ECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE) | BioActive Nutritional, Inc. | 9c9ed6f6-8690-4fbd-8691-26dd577014a8 | 2024-09-11 | Warnings | ETJ7Z6XBU4 |
| Lymph Liquescence | ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ARSENICUM IODATUM, CURCUMA LONGA, SPLEEN (BOVINE), THYMUS (OVINE), CONIUM MACULATUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, SILICEA, ASTERIAS RUBENS, HYDRASTIS CANADENSIS, BUFO RANA | Nutritional Specialties, Inc. | 866ac8e1-431c-4c8b-b052-f6c4cff3769b | 2024-09-05 | Warnings | ETJ7Z6XBU4 |
| Sensodyne Pronamel Gentle Whitening Advanced | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 94e07979-943b-45bb-8e2b-90d686f3692e | 2024-09-04 | Warnings | 8ZYQ1474W7 |
| Sensodyne Pronamel Gentle Whitening Advanced Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | 6eb304dd-2a24-4fa0-9d39-71264e88dd16 | 2024-08-29 | Warnings | 8ZYQ1474W7 |
| Geopathic Stress | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, SYMPHYTUM OFFICINALE, AGATE, CALCAREA CARBONICA, FERRUM METALLICUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, X-RAY, CUPRUM METALLICUM, TARENTULA HISPANA | BioActive Nutritional, Inc. | 7f4a18fc-1188-4201-85d5-f2d4d9d3fb7b | 2024-08-29 | Warnings | ETJ7Z6XBU4 |
| ASP | ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), ARSENICUM ALBUM, BRYONIA (ALBA), COCCULUS INDICUS, COLCHICUM AUTUMNALE, LEDUM PALUSTRE, MERCURIUS CYANATUS, NATRUM SULPHURICUM, PULSATILLA (PRATENSIS), SEPIA, SILICEA, AFLATOXIN (B1) | BioActive Nutritional, Inc. | 66fe5457-fe15-4e33-b47e-2c0dc9b171f6 | 2024-08-28 | Warnings | ETJ7Z6XBU4 |
| ACT Anticavity Fluoride Arctic Blast | SODIUM FLUORIDE | Chattem, Inc. | 2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57 | 2024-08-22 | Warnings | M021 8ZYQ1474W7 |
| CinnaFresh | SODIUM FLUORIDE | Bob Barker Company Inc. | 3fbd95f0-a10c-4351-ad80-7e90b2d6a6f5 | 2024-08-22 | Warnings | M021 245598 8ZYQ1474W7 |
| Sensodyne Pronamel Clinical Enamel Strength Deep Clean | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | cfda7efa-86fa-470d-a79f-81907e31778a | 2024-08-14 | Warnings | 8ZYQ1474W7 |
| Sensodyne Pronamel Kids Bubble Twist | SODIUM FLUORIDE | Haleon US Holdings LLC | e403529a-0fac-4dab-b75c-46906add096b | 2024-08-13 | Warnings | 8ZYQ1474W7 |
| Vermiclear | GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM | Energique, Inc. | f9df74a8-f225-44ca-91ba-dca4f3f35da0 | 2024-08-13 | Warnings | ETJ7Z6XBU4 |
| Empathy | AETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATA | Deseret Biologicals, Inc. | a89067c1-ef12-49da-8fa6-e65ff664f497 | 2024-08-13 | Warnings | 059QF0KO0R |
| Karl and Hans Botanic Double Mint | SODIUM MONOFLUOROPHOSPHATE | PIGEON CORPORATION | d1233fc3-047c-4e26-bb2b-8ebde09c05a9 | 2024-08-08 | Warnings | M021 |
| Karl and Hans Botanic Jasmine | SODIUM MONOFLUOROPHOSPHATE | PIGEON CORPORATION | 6c0335e6-f041-48c7-9da3-88c124b84b00 | 2024-08-08 | Warnings | M021 |
| Sodium Fluoride Chewable | SODIUM FLUORIDE | Bryant Ranch Prepack | 4ce32ee3-cd20-4663-a169-fa78ebd20477 | 2024-08-05 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| OMNI | STANNOUS FLUORIDE | Solventum US LLC | 0c2a81b1-65b5-432b-8e66-30432a245aba | 2024-08-01 | Warnings | M021 |
| Just For Kids | STANNOUS FLUORIDE | Solventum US LLC | 0f1afc36-f699-4072-b90b-c9f5be989a49 | 2024-08-01 | Warnings | M021 |
| Clinpro Tooth Creme | SODIUM FLUORIDE | Solventum US LLC | 786c6184-6bc8-4376-9ce2-3e35af193210 | 2024-08-01 | Warnings | M021 8ZYQ1474W7 |
| PerioMed | STANNOUS FLUORIDE | Solventum US LLC | 7f79eb00-86df-4284-b415-47f45e4849da | 2024-08-01 | Warnings | M021 |
| Mind Detox and Drainage | ALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUM | Deseret Biologicals, Inc. | 1ac1e955-a374-4cac-b997-51c6aef8d35d | 2024-08-01 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.