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 |
|---|---|---|---|---|---|---|
| Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f0b1d46-d52c-f409-e063-6394a90a5574 | 2026-06-25 | M021 8ZYQ1474W7 | |
| Crest Plus Extra Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 5514e09e-0a7d-93e6-e063-6294a90ae3f0 | 2026-06-25 | Warnings | M021 8ZYQ1474W7 |
| Chemstat | GLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, | Energique, Inc. | 2e361b50-9268-4053-b13c-93af64549848 | 2026-06-25 | Warnings | 506T60A25R |
| Colgate Sparkling White Mint Zing | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 0c2fe62b-4905-4213-a85b-e073d8eeb741 | 2026-06-24 | Warnings | M021 |
| Colgate MaxFresh Charcoal | SODIUM FLUORIDE | Colgate-Palmolive Company | 890c4c29-bba8-4775-a053-10c6292df930 | 2026-06-24 | Warnings | M021 8ZYQ1474W7 |
| Crest Premium Plus Active Foam Whitening scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 55004d9d-eda7-a285-e063-6294a90ad4ca | 2026-06-24 | Warnings | M021 8ZYQ1474W7 |
| Euthymol Whitening Purple Corrector | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 5500686c-d417-c50a-e063-6294a90ac7fa | 2026-06-24 | Warnings | M021 8ZYQ1474W7 |
| Crest Premium Plus Scope Active Foam plus Whitening Dualblast Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 5500f9ab-b0c4-51d6-e063-6394a90acd38 | 2026-06-24 | Warnings | M021 8ZYQ1474W7 |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37dead3e-60cb-88ae-e063-6294a90a8f70 | 2026-06-24 | Warnings | 059QF0KO0R |
| Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 5504ec96-aae1-f5f9-e063-6294a90ad8bb | 2026-06-24 | Warnings | M021 8ZYQ1474W7 |
| COLGATE SPARKLING WHITE CINNAMINT | SODIUM FLUORIDE | Colgate-Palmolive Company | f2ff18d2-4ef0-454e-a6f1-6f3bf361c7d1 | 2026-06-24 | Warnings | M021 8ZYQ1474W7 |
| Crest Plus Scope plus Whitening Minty Fresh with Mouthwash | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 54ed8e02-3c2f-750c-e063-6394a90a4d33 | 2026-06-23 | Warnings | M021 8ZYQ1474W7 |
| Bacteriostatic Water | BACTERIOSTATIC WATER | Fujian Genohope Biotech Ltd. | 54f66b82-c9e5-a2bc-e063-6394a90adbbc | 2026-06-23 | 059QF0KO0R | |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | H E B | c68b0644-685d-4c62-bf5d-3a5bbea3b052 | 2026-06-22 | Warnings, Adverse reactions | M021 8ZYQ1474W7 |
| PreviDent 5000 Plus Fruitastic | SODIUM FLUORIDE | Colgate Oral Pharmaceuticals Inc. | 5ef93306-59dd-447b-a2ec-dd865e52c76b | 2026-06-18 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| PreviDent 5000 Booster Plus Spearmint | SODIUM FLUORIDE | Colgate Oral Pharmaceuticals, Inc. | 4ef2b7ed-41c3-41cb-8ee0-1930ab8fb198 | 2026-06-18 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| PreviDent Alcohol Free | SODIUM FLUORIDE | Colgate Oral Pharmaceuticals, Inc. | 28e4f7cd-9fd8-4c7a-9e4b-d747fefc76c0 | 2026-06-17 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Humalog | INSULIN LISPRO | Eli Lilly and Company | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f | 2026-06-16 | Warnings, Adverse reactions | 059QF0KO0R |
| Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | fdbadaae-eab7-4d9a-acf7-815ca93f877c | 2026-06-16 | Warnings | M021 |
| H-Scars Formula | CALENDULA OFFICINALLIS, SILICEA | Healing Natural Oils LLC | 8433ff00-d815-45e0-b0ec-1448668dd8f8 | 2026-06-16 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.