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 |
|---|---|---|---|---|---|---|
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d40b98b-2e9a-d84a-e063-6294a90a2096 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d44863e-93be-2b80-e063-6294a90a4a9d | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d458ccc-8f1e-f9c8-e063-6294a90a8da4 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d447939-fbf6-42f6-e063-6294a90af6d9 | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1de591d9-9cab-e63d-e063-6394a90ac8eb | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Ice Pop Flavor Sodium Fluoride Anticavity Toothpast | SODIUM FLUORIDE | HISMILE PTY LTD | 20e1603e-bcd1-6a5e-e063-6294a90ad1db | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Hismile | CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | HISMILE PTY LTD | 1e725b7e-accc-f51c-e063-6394a90a455c | 2026-01-15 | Warnings | M021 8ZYQ1474W7 |
| Walgreens Sterile Soothing Eye Wash | PURIFIED WATER | Walgreens | a62e3294-abd6-48dc-81b1-62a809bdc968 | 2026-01-14 | Warnings | 059QF0KO0R |
| Colgate Sensitive Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | 3b656928-af58-4ee9-8fb8-360688eb9bf3 | 2026-01-13 | Warnings | 8ZYQ1474W7 |
| Enamelon Preventive Treatment | STANNOUS FLUORIDE | Premier Dental Products Company | 04c3f178-7905-404d-9ac2-67c453287ddf | 2026-01-13 | Warnings | M021 |
| Enamelon | STANNOUS FLUORIDE | Premier Dental Products Company | 1626375a-f78b-4192-b7f3-ca932acab7fb | 2026-01-13 | Warnings | M021 |
| ARU CAVITY PROTECTION | SODIUM FLUORIDE | Ashtel Studios, Inc. | 97bd2934-4bff-4fdb-9199-fcdc0f77fada | 2026-01-13 | Warnings | M021 8ZYQ1474W7 |
| Colgate Sensitive Enamel Health | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | a50d4259-8a79-417e-b381-72c7a8ec0418 | 2026-01-13 | Warnings | 8ZYQ1474W7 |
| ACT Anticavity Fluoride Cinnamon | SODIUM FLUORIDE | Chattem, Inc. | f2952ca5-c1c3-42fc-82a4-08662286be44 | 2026-01-12 | Warnings | M021 8ZYQ1474W7 |
| ACT Anticavity Fluoride Kids Wild Watermelon | SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION) | Chattem, Inc. | bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8 | 2026-01-12 | Warnings | M021 8ZYQ1474W7 |
| ACT Kids Anticavity Fluoride Pineapple Punch | SODIUM FLUORIDE | Chattem, Inc. | 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b | 2026-01-12 | Warnings | M021 8ZYQ1474W7 |
| Botao Kids Strawberry Flavored with Fluoride | BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE | Peer Pharm Ltd. | 48b8d884-5e15-4145-8521-ae9ee482e392 | 2026-01-12 | Warnings | M021 245598 8ZYQ1474W7 |
| Constipation Relief | ALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDE | Homeocare Laboratories | 62374240-cd14-44e2-9405-5f8996faf047 | 2026-01-12 | Warnings | ETJ7Z6XBU4 |
| Menopause Relief | BARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDE | Homeocare Laboratories | 99b182d5-4102-4b25-85d3-f4be077d753f | 2026-01-12 | Warnings | ETJ7Z6XBU4 |
| Amber Amethyst | AMBER AMETHYST | Uriel Pharmacy, Inc | 4837e805-a777-c1fa-e063-6294a90ae9c4 | 2026-01-12 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.