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 |
|---|---|---|---|---|---|---|
| Zap Neutral | SODIUM FLUORIDE | Crosstex International Inc. | e1dc8865-a193-44e7-b628-3c4e5d595318 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 6c1907d6-5b22-40fc-b94e-42af7b523902 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | fdf5c2e5-9939-448f-99ec-4de513e32fc1 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | c2d3d7f9-00cf-4d85-af51-71f150cd0289 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 080e7f9d-273e-4f3b-bc84-f7c0dd3cf94c | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 01d48cbb-fbd6-477f-81ce-1e388718a431 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | b1d799c6-e483-44fd-b07c-94ca2ee239ef | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | c33e0e2e-7c68-4908-8bd4-6a3669c8774b | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| EAR RX | ACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUM | Miami Beach Pediatrics pa | a8753f88-4b8a-472f-a4bd-f2e9cec83610 | 2021-12-29 | Warnings | ETJ7Z6XBU4 |
| Lyme Disease Support 2 | ARGENTUM NITRICUM, ASTRAGALUS MENZIESII, CALCAREA SULPHURICA, CUPRUM ARSENICOSUM, DNA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI SULPHURICUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, RNA, SILICEA. | OHM PHARMA INC. | 13b4b78b-f9f7-4cf6-8f43-61679160086b | 2021-12-29 | Warnings | ETJ7Z6XBU4 |
| Lyme Disease Support 1 | ALUMEN, CALCAREA CARBONICA, DNA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI CARBONICUM, KALI MURIATICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, RNA, SILICEA. | OHM PHARMA INC. | 035e75d6-aeef-4dfd-b076-9d3d8e4a5086 | 2021-12-29 | Warnings | ETJ7Z6XBU4 |
| OHM Skin Healing Cream | CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA. | OHM PHARMA INC. | c12e6706-37f0-4900-856c-fc7e7ac3b724 | 2021-12-29 | Warnings | ETJ7Z6XBU4 |
| OHM Skin Healing Gel | CALENDULA OFFICINALIS, STELLARIA MEDIA, CALCAREA SULPHURICA, CHAMOMILLA, ECHINACEA ANGUSTFOLIA, SILICEA, SYMPHYTUM OFFICINALE, THIOSINAMIUM, HAMAMELIS VIRGINIANA. | OHM PHARMA INC. | f97dffe6-cddc-4577-afcc-deadb7abd0c6 | 2021-12-29 | Warnings | ETJ7Z6XBU4 |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM | Energetix | 75826e2a-737a-43ac-aed7-fad960889b88 | 2021-12-15 | Warnings | ETJ7Z6XBU4 |
| HAIR STIM | PEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINOR | The Wellness Center for Research and Education, Inc. | d5c75dc2-9edc-429e-8f25-e5641fe5042f | 2021-11-23 | Warnings | ETJ7Z6XBU4 |
| CONSTIPATION CP | ALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE. | Natural Creations, Inc. | 961b3ddf-41fe-46ed-b5e4-0fd8d9652edf | 2021-11-15 | Warnings | ETJ7Z6XBU4 |
| CENTROCODE | AMERICAN GINSENG, ADENOSINE TRIPHOSPHATE, CORTICOTROPIN, ALFALFA, BOS TAURUS HYPOTHALAMUS, PHYTOLACCA AMERICANA ROOT, BOS TAURUS PITUITARY GLAND POSTERIOR, THYROID UNSPECIFIED, IODINE, SILICON DIOXIDE, OSTER SHELL CALCIUM CARBONATE CRUDE, STRYCHNOS IGNATII SEED, IRIDIUM, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, SELENIUM, URANYL NITRATE HEXAHYDRATE. | Natural Creations, Inc. | e5bbe9ec-7602-4de5-907a-7047c10198b6 | 2021-11-15 | Warnings | ETJ7Z6XBU4 |
| Hydrate 2 | BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA | Natural Creations, Inc | 52cb98dc-6858-42bf-9c54-d20fb607dfbb | 2021-11-12 | Warnings | ETJ7Z6XBU4 |
| KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT | SODIUM FLUORIDE | DMG AMERICA, LLC | b83c62be-8e9d-4fa2-aa10-d34c88bf2387 | 2021-10-01 | Warnings | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.