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 |
|---|---|---|---|---|---|---|
| DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATE | ATOSAFE CO., Ltd | 487c5036-0eb0-ada9-e063-6394a90aa02e | 2026-01-16 | Warnings | 8ZYQ1474W7 ETJ7Z6XBU4 |
| DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATE | DONG IL PHARMS CO.,LTD | 487cd5b9-28f3-392d-e063-6394a90a9ba1 | 2026-01-16 | Warnings | 8ZYQ1474W7 ETJ7Z6XBU4 |
| DENTI BUONGIORNO GUM CARE COOL MINT TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE | ATOSAFE CO., Ltd | 487cf27a-d761-6353-e063-6394a90af029 | 2026-01-16 | Warnings | 8ZYQ1474W7 ETJ7Z6XBU4 |
| DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTH | SILICA, SODIUM MONOFLUOROPHOSPHATE | ATOSAFE CO., Ltd | 487d52d1-8853-bc90-e063-6394a90ab91d | 2026-01-16 | Warnings | ETJ7Z6XBU4 |
| DENTI BUONGIORNO GUM CARE COOL MINT TOOTH | SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE | DONG IL PHARMS CO.,LTD | 487d689d-ebdd-43c3-e063-6294a90af0e2 | 2026-01-16 | Warnings | 8ZYQ1474W7 ETJ7Z6XBU4 |
| DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTH | SILICA, SODIUM MONOFLUOROPHOSPHATE | DONG IL PHARMS CO.,LTD | 487da363-1d01-8cdc-e063-6294a90ac24d | 2026-01-16 | Warnings | ETJ7Z6XBU4 |
| Berberis Quartz | BERBERIS QUARTZ | Uriel Pharmacy Inc. | 5da48d70-1140-495d-b672-0e55c04196e1 | 2026-01-16 | Warnings | ETJ7Z6XBU4 |
| Family Care Single Use Lubricant Eye Drop 0.4mL 5ct | CARBOXYMETHYLCELLULOSE SODIUM | United Exchange Corp | 48879feb-b5ae-a9e6-e063-6394a90a03b2 | 2026-01-16 | Warnings | K679OBS311 |
| Family Care Single Use Lubricant Eye Drop 0.4mL 30ct | CARBOXYMETHYL CELLULOSE 0.5% | United Exchange Corp | 488b3363-8d06-7dcc-e063-6294a90ab44c | 2026-01-16 | Warnings | K679OBS311 |
| Sodium Flouride | SODIUM FLUORIDE | AvKARE | 92fef2e0-f9f2-8b0f-e053-2995a90a096a | 2026-01-15 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Hismile | PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0eba92d1-cbdc-9c96-e063-6294a90a9afc | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3cfb6-6bae-1682-e063-6394a90aca88 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3f4f8-fdc4-2056-e063-6394a90a6fd7 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef41051-dfa0-b105-e063-6294a90a551f | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef43107-58ec-d4ee-e063-6294a90ad8d7 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef56539-dc21-c6ea-e063-6394a90a5790 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef6f8b5-8565-b364-e063-6294a90aabbc | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef766ae-754a-f185-e063-6294a90a3299 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef7be5b-df8f-9f32-e063-6394a90a4724 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef8d0ef-a051-f610-e063-6394a90a8537 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.