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 |
|---|---|---|---|---|---|---|
| Ionite APF Neutral | SODIUM FLUORIDE | Dharma Research, inc. | ad7a660b-274c-417e-bdf3-1d5addf06ad1 | 2020-11-18 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | 8ff1b377-0535-4548-a109-f9f1a43b85b7 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | e6c31330-43e0-4d32-af54-ff852af39cab | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | b8b7f9b8-ff11-4a76-ab36-7822c15e1892 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | e1797adf-4665-4322-a3aa-dd2da9dcd3a8 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | ce34c159-34cd-47c7-937f-743b3309742b | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | 503ca71a-f50c-4406-b925-5b6ac36a9212 | 2020-11-15 | Warnings | 8ZYQ1474W7 |
| Ionite R | SODIUM FLUORIDE | Dharma Research, Inc. | 1009afc7-6e9d-417f-a702-f8a941e08484 | 2020-11-06 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Ionite R | SODIUM FLUORIDE | Dharma Research, Inc. | 0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5 | 2020-11-06 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, inc. | d22afac7-45d6-467e-951a-e7c241b9180d | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, inc. | 4828b482-486f-4105-bed0-3fe2ddbbddb1 | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, Inc. | 8987b447-3fa3-4f52-aecc-80e44c981aaa | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Neutral | SODIUM FLUORIDE | Dharma Research, inc. | 8191554f-adb6-4ba9-aa80-0a9bb65193ec | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, inc. | ddd34623-cb79-4fa7-bd01-19122470b63d | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| GUNA MATRIX DETOX | SODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS - | Guna spa | a369b95b-4d57-f149-e053-2995a90a87e3 | 2020-10-23 | Warnings, Adverse reactions | ETJ7Z6XBU4 |
| Supreme | ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA | BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE | 72c4679b-aa97-4888-9178-581d0f99c0b6 | 2020-09-11 | Warnings | ETJ7Z6XBU4 |
| FluoriMax 5000 | 1.1% SODIUM FLUORIDE TOOTHPASTE | Elevate Oral Care | ae45ae2d-a21f-0a05-e053-2995a90a4d5e | 2020-09-01 | Warnings | 8ZYQ1474W7 |
| FluoriMax 5000 Sensitive | 1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE | Elevate Oral Care | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 2020-08-31 | Warnings | 8ZYQ1474W7 |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.