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 |
|---|---|---|---|---|---|---|
| Optimax Anticavity Fluoride Raspberry | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 57e1d1cb-da58-4cd2-b960-4056e0b0d214 | 2026-06-05 | Warnings | M021 |
| REFRESH CELLUVISC | CARBOXYMETHYLCELLULOSE SODIUM | Allergan, Inc. | b32ed9e8-d091-4f16-b416-5a62cdfee49a | 2026-06-05 | Warnings | K679OBS311 |
| Vermex | ARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUM | BioActive Nutritional, Inc. | 6be5fbcf-bb22-4b20-b65a-d943c516adf9 | 2026-06-04 | Warnings | ETJ7Z6XBU4 |
| BM Silicea Icing Sugar | SILICEA ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 535ba100-627f-36b4-e063-6394a90a3373 | 2026-06-03 | Warnings | ETJ7Z6XBU4 |
| 3ECARE Dual FormulaWhiteningToothpaste | SODIUM FLUORIDE | Hangzhou Namei Zhikang Technology Co., Ltd. | 533fb7dd-7f84-59c5-e063-6394a90accad | 2026-06-02 | Warnings | M021 8ZYQ1474W7 |
| 3ECARE Dual FormulaToothpastefor sensitiveteeth | POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE | Hangzhou Namei Zhikang Technology Co., Ltd. | 533fc83e-a8cf-15c1-e063-6294a90a7b74 | 2026-06-02 | Warnings | M021 |
| Walgreens Restore and Defend | STANNOUS FLUORIDE | Walgreens | e808ea4b-9081-085b-e053-2a95a90a4f9b | 2026-06-02 | Warnings | M021 |
| Hello Unicorn Splash unicorn splash anticavity fluoride rinse | SODIUM FLUORIDE | Colgate-Palmolive Company | a1014431-7d23-aaff-6dc7-ab58683d0338 | 2026-06-02 | Warnings | M021 8ZYQ1474W7 |
| BM Tooth Remineralization | CALC PHOS, CALC FLUOR, SILICEA | BM Private Limited | 5331dc40-2ac8-5fce-e063-6394a90a5875 | 2026-06-01 | Warnings | ETJ7Z6XBU4 |
| Therabreath Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | feab3d45-ff95-4b32-8258-7d932a7380c9 | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| Orajel Toy Story 5 Anticavity | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b80947d-f389-2f80-e063-6294a90abd55 | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 54113245-0c1e-739e-e063-6294a90aea42 | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| Arm and Hammer | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 545258fd-8179-fffc-e063-6394a90a467f | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| Orajel Paw Patrol | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d87bea-3e99-5d04-e053-2a95a90aaf54 | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| Orajel SuperMario | ANTICAVITY TOOTHPASTE | Church & Dwight Co., Inc. | 27d2f6cb-8661-da9c-e063-6394a90a5bde | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| Orajel KidsToothpaste | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 99d62125-c2c5-5926-e053-2995a90aaa29 | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| AIM CAVITY PROTECTION Multi Benefit | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0f8a33-0b01-40e2-e054-00144ff88e88 | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| Crest plus Tartar Protection Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 560980ea-749f-593d-e063-6394a90a1b9e | 2026-06-01 | Warnings | M021 8ZYQ1474W7 |
| C-More Lubricant Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | PROFOUND NUTRITION LIMITED | 78f04ecb-da5e-468c-81fe-70f7c26b76c2 | 2026-06-01 | Warnings | K679OBS311 |
| Charm Tex FLUORIDE Gel | SODIUM FLUORIDE | Jiangsu Gold Worldworks Household Chemicals Co., Ltd. | 09d47bd7-1438-4ef2-85e0-9cd5eb2f763a | 2026-05-31 | Warnings | 245598 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.