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 |
|---|---|---|---|---|---|---|
| Natural Fluoride Fresh Mint cavity protection whitening fresh breath | SODIUM FLUORIDE | Tom's of Maine, Inc. | fce5e8b5-34f8-4a45-a662-82c903419809 | 2026-06-16 | Warnings | M021 8ZYQ1474W7 |
| Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | ebb62015-0027-459a-a9cf-56b640f9f456 | 2026-06-16 | Warnings | M021 |
| Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | b9962eac-186e-4da2-929d-393f18ed0234 | 2026-06-16 | Warnings | M021 |
| Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 1c029b10-29b0-4131-9134-cebfca4328a3 | 2026-06-16 | Warnings | M021 |
| Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR | SODIUM MONOFLUOROPHOSPHATE | Tom's of Maine, Inc. | 3e7ab39a-989c-4924-af3e-689404912bee | 2026-06-16 | Warnings | M021 |
| E-Z-GAS II | ANTACID/ANTIFLATULENT | E-Z-EM, INC. | 4e12e1cb-b033-076d-e054-00144ff8d46c | 2026-06-15 | Warnings | ETJ7Z6XBU4 |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | ETJ7Z6XBU4 |
| Lubricant Eye | CARBOXYMETHYLCELLULOSE SODIUM 0.5% | CARDINAL HEALTH 110, LLC. DBA LEADER | 51a2d74f-5ff3-9921-e063-6294a90a345a | 2026-06-15 | Warnings | K679OBS311 |
| Lubricant Eye | CARBOXYMETHYLCELLULOSE SODIUM | Rugby Laboratories | 51cadca6-a31b-c1b5-e063-6394a90a34d3 | 2026-06-15 | Warnings | K679OBS311 |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 543bc298-ec32-38e9-e063-6394a90aac15 | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Nail Fungus Control Extra Strength | CALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUM | Forces of Nature | d02b88a6-1999-4dcd-91b5-fad88a664fcb | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Nerve Pain | ARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUM | Forces of Nature | a9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb7 | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| Scar Control | CALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDE | Forces of Nature | 595c3423-6b52-48fc-8a95-00b53c1ecc7b | 2026-06-14 | Warnings | ETJ7Z6XBU4 |
| BM BM186 DROPS | ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 54243745-bd67-19c1-e063-6394a90a4b72 | 2026-06-13 | Warnings | ETJ7Z6XBU4 |
| PreviDent 5000 Enamel Protect | SODIUM FLUORIDE AND POTASSIUM NITRATE | Colgate Oral Pharmaceuticals, Inc. | bbc66b1b-e05c-4e14-bef3-b8bae419fc89 | 2026-06-12 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| BM BM186 DROPS | ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA | BM Private Limited | 540d8fbe-3bdb-1b54-e063-6394a90a114d | 2026-06-12 | Warnings | ETJ7Z6XBU4 |
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 540e4ee3-596f-4cea-e063-6294a90a6a60 | 2026-06-12 | Warnings | ETJ7Z6XBU4 |
| BM BM70 DROPS | ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 54113d1f-e8e7-6b4c-e063-6394a90a0edf | 2026-06-12 | Warnings | 059QF0KO0R |
| PreviDent OrthoDefense | SODIUM FLUORIDE | Colgate Oral Pharmaceuticals, Inc. | 99d37f3e-ac4f-4e8f-92e3-9b27d7632d35 | 2026-06-12 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| BM BM70 DROPS | ANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALB | BM Private Limited | 53fa21d9-1f80-2e69-e063-6394a90ab9f3 | 2026-06-11 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.