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 |
|---|---|---|---|---|---|---|
| Dentalclean Green Diamond Alcohol Free Mouthwash | SODIUM FLUORIDE 0.05% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 5653aa33-4f0e-46b2-9be0-6219143556ec | 2025-07-14 | Warnings | M021 8ZYQ1474W7 |
| Flotrex | MULTIVITAMINS, SODIUM FLUORIDE 0.5 MG | PureTek Corporation | 2e0e51f3-ee2c-540d-e063-6294a90a9275 | 2025-07-14 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Flotrex | MULTIVITAMINS, SODIUM FLUORIDE 0.25 MG | PureTek Corporation | 30186998-2121-3ef2-e063-6394a90a513e | 2025-07-14 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Colgate Total Gum Protect Fresh Mint | STANNOUS FLUORIDE | COLGATE PALMOLIVE COMPANY | 570e3bd6-eede-4270-9d78-055aeb2b8c17 | 2025-07-14 | Warnings | M021 |
| Endocrinpath | ALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE) | Energetix Corporation | 70f84941-b8a1-48f4-9c05-554e554f0049 | 2025-07-11 | Warnings | ETJ7Z6XBU4 |
| Sterile Water | STERILE WATER | Nephron Pharmaceuticals Corporation | bc04a883-babc-87a6-e053-2995a90a3dfd | 2025-07-11 | Warnings, Adverse reactions | 059QF0KO0R |
| OraPro Fluoride Anticavity | FLUORIDE TOOTHPASTE | Protegera, Inc. | 93b0181c-e29f-42f4-80f5-366463b68f09 | 2025-07-10 | Warnings | M021 8ZYQ1474W7 |
| Enamur Fluoride AntiCavity Toothpast | FLUORIDE TOOTHPAST | Protegera, Inc | 557ced45-f54e-43d8-aa13-46f75b79367c | 2025-07-10 | Warnings | M021 8ZYQ1474W7 |
| Flotrex | MULTIVITAMINS, SODIUM FLUORIDE 1 MG | PureTek Corporation | 399c637c-0e25-9b11-e063-6294a90a4c28 | 2025-07-10 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12 | SILICEA | Martin & Pleasance Pty Ltd | 39620db9-5099-47f0-93ad-c00e6625c462 | 2025-07-07 | Warnings | ETJ7Z6XBU4 |
| Super Strawberry | STRAWBERRY TOOTHPASTE | SuperMouth, LLC. | a8c2b68d-d28b-41c0-a383-cc706b25aa1a | 2025-07-05 | Warnings | M021 8ZYQ1474W7 |
| Super Mint | SUPER MINT TOOTHPASTE | SuperMouth, LLC. | be0915f3-36c4-4200-9d15-704cfbd632b4 | 2025-07-05 | Warnings | M021 8ZYQ1474W7 |
| Super Vanilla | VANILLA TOOTHPASTE | SuperMouth, LLC. | 3ddfe20a-86f1-4566-bb77-82c9749411f6 | 2025-07-05 | Warnings | M021 8ZYQ1474W7 |
| Super Chocolate | CHOCOLATE TOOTHPASTE | SuperMouth, LLC. | 48607622-7c5e-4ddc-8d83-707f26c0553f | 2025-07-05 | Warnings | M021 8ZYQ1474W7 |
| Sensodyne Pronamel Kids Berry Twist | SODIUM FLUORIDE | Haleon US Holdings LLC | 69c07c36-b5e0-420b-ab29-7d1091386322 | 2025-07-03 | Warnings | 8ZYQ1474W7 |
| Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT | SODIUM FLUORIDE | Ashtel Studios, Inc. | 13dba3ce-88a8-490c-a906-cfd206d1d290 | 2025-07-01 | Warnings | M021 8ZYQ1474W7 |
| evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT | SODIUM FLUORIDE | Ashtel Studios, Inc. | baae4f4a-54ef-472a-9c94-31703435750b | 2025-07-01 | Warnings | M021 8ZYQ1474W7 |
| Arnica Calendula Wound | ARNICA CALENDULA WOUND | Uriel Pharmacy, Inc | 38cfd292-4dbd-2caf-e063-6394a90a0527 | 2025-06-30 | Warnings | ETJ7Z6XBU4 |
| Bac | APIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDE | Zorex | 7ae38e0c-8e74-4fd5-8605-45e424a84d01 | 2025-06-30 | Warnings | ETJ7Z6XBU4 |
| Bambusa Aurum | BAMBUSA AURUM | Uriel Pharmacy Inc. | 43f3dd30-701f-4fa4-9743-d10051c6e6d4 | 2025-06-27 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.