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 |
|---|---|---|---|---|---|---|
| MycoCan-Chord | ALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUM | Energetix Corporation | 227199f8-a45e-44ff-892d-ade4fefea354 | 2026-08-11 | Warnings | ETJ7Z6XBU4 |
| TOMS OF MAINE WHOLE CARE SPEARMINT | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 08d7ed04-67a4-437a-82c5-496f9893c6c7 | 2026-08-10 | Warnings | M021 |
| TOMS OF MAINE WICKED FRESH COOL PEPPERMINT | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 27278b02-c4fd-4092-a632-a14e442f5a95 | 2026-08-10 | Warnings | M021 |
| TOMS OF MAINE WICKED FRESH SPEARMINT ICE | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 59a6b9ac-c28b-4ec3-8231-f35054ce0eaf | 2026-08-10 | Warnings | M021 |
| Toms Kids Watermelon Wiggle | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 48eaafb6-99f4-5fd1-10fc-4ea35cbb2c62 | 2026-08-10 | Warnings | M021 |
| AutoBrush kids bubblegum | SODIUM FLUORIDE | Lander Enterprises, LLC | 64b60e74-fceb-4de9-a966-73bf8dbd666c | 2026-08-10 | Warnings | M021 8ZYQ1474W7 |
| AutoBrush kids strawberry | SODIUM FLUORIDE | Lander Enterprises, LLC | 7e880d50-8aab-4d57-abc1-e900070f9a11 | 2026-08-10 | Warnings | M021 8ZYQ1474W7 |
| AutoBrush kids watermelon | SODIUM FLUORIDE | Lander Enterprises, LLC | 5cb5eb46-705c-4bb7-bef1-e93a598636fd | 2026-08-10 | Warnings | M021 8ZYQ1474W7 |
| AutoBrush Mint | SODIUM FLUORIDE | Lander Enterprises, LLC | 0e043431-9d87-478d-87f5-5aa8b0a932eb | 2026-08-10 | Warnings | M021 8ZYQ1474W7 |
| Willo Minty Mist Dye Free | SODIUM FLUORIDE | Willo 32, Inc. | 3ee5b49e-ca9a-ece6-e063-6394a90a3d00 | 2026-08-10 | Warnings | M021 8ZYQ1474W7 |
| Willo Bubble Twist | SODIUM FLUORIDE | Willo 32 Inc | 36560d62-e901-1f93-e063-6394a90a2803 | 2026-08-10 | Warnings | M021 245598 8ZYQ1474W7 |
| Willo Berry Splash Dye Free | SODIUM FLUORIDE | Willo 32, Inc | 3ea91af9-2895-e530-e063-6394a90a39e5 | 2026-08-10 | Warnings | M021 245598 8ZYQ1474W7 |
| Fluoride Mouth Rinse Anticavity | SODIUM FLUORIDE | Target Corporation | 3daf3cc3-585a-4bb2-9b56-7117d220ed38 | 2026-08-10 | Warnings, Adverse reactions | M021 8ZYQ1474W7 |
| TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 19de1e71-ab94-415f-b66d-e5748dea8317 | 2026-08-10 | Warnings | M021 |
| TOMS OF MAINE WHOLE CARE WINTERMINT | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | d5e1396e-0253-4ec0-a9ff-b61bda70de35 | 2026-08-10 | Warnings | M021 |
| TOMS OF MAINE WICKED COOL MILD MINT | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | de92408c-d401-47c3-94ee-fb6c08092651 | 2026-08-10 | Warnings | M021 |
| TOMS OF MAINE ACTIVATED CHARCOAL PEPPERMINT | SODIUM FLUORIDE | Tom's of Maine, Inc. | b9e6e455-8444-4805-89f1-ee9142f98e36 | 2026-08-10 | Warnings | M021 8ZYQ1474W7 |
| TOMS OF MAINE WHOLE CARE SPEARMINT | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 7db8e49d-1073-4a81-a3a4-f3a19ebce921 | 2026-08-10 | Warnings | M021 |
| TOMS OF MAINE WHITEN PLUS DEEP CLEAN SPEARMINT | SODIUM FLUORIDE | Tom's of Maine, Inc. | 1fe50b49-bc62-4137-866c-e87bb878a96d | 2026-08-10 | Warnings | M021 8ZYQ1474W7 |
| Sterile Water | WATER | Cardinal Health 107, LLC | 48d75a7c-8329-48a8-bea0-a8c144ddf637 | 2026-08-07 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.