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 Plus Cinnamon plus Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 53fb780d-3e8b-6747-e063-6294a90a8211 | 2026-06-11 | Warnings | M021 8ZYQ1474W7 |
| Jacksons Cell Salts SKIN BALANCE | CALC SULPH, KALI SULPH, SILICEA | Zettl Health Inc. | 54012f03-4c34-42f5-e063-6394a90aacc5 | 2026-06-11 | Warnings | ETJ7Z6XBU4 |
| Colgate Total SF Whitening | STANNOUS FLUORIDE | COLGATE PALMOLIVE COMPANY | 7f6b6aa8-50da-151b-c448-9e427d37398f | 2026-06-11 | Warnings | M021 |
| Colgate MaxClean with Whitening Smartfoam | SODIUM FLUORIDE | Colgate-Palmolive Company | c712ae6b-eff3-4c54-b1fc-37304758d059 | 2026-06-11 | Warnings | M021 8ZYQ1474W7 |
| BM BM5 DROPS | APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC | BM Private Limited | 53e763ee-9a44-a914-e063-6394a90aeb3c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| GUNA-AWARENESS | BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - | Guna spa | 10e46b39-7903-4390-b72d-865291245b4c | 2026-06-10 | Warnings | ETJ7Z6XBU4 |
| Colgate Total Sensitivity Mineral Shield | STANNOUS FLUORIDE | Colgate-Palmolive Company | f065318c-1e2a-c04d-f254-f8127b05a88f | 2026-06-10 | Warnings | M021 |
| Toms Whole Care Mouthwash Fresh Mint | SODIUM FLUORIDE | Tom's of Maine, Inc. | 6875f5c1-853c-43da-8226-c09a5518f9bb | 2026-06-10 | Warnings | M021 8ZYQ1474W7 |
| PreviDent 5000 Dry Mouth | SODIUM FLUORIDE | Colgate Oral Pharmaceuticals, Inc. | d93ee76f-454b-40bf-9357-39a2ae3b6ccb | 2026-06-10 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| PreviDent 5000 Kids | SODIUM FLUORIDE | Colgate Oral Pharmaceuticals, Inc. | 29a110f3-f407-fdfa-4346-937269ca849b | 2026-06-10 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Colgate Total SF Fresh Mint Stripe | STANNOUS FLUORIDE | COLGATE PALMOLIVE COMPANY | 657020c7-e85c-4c61-9f62-b50351e4b4e5 | 2026-06-10 | Warnings | M021 |
| 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 | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| Optimax Anticavity Fluoride Bubblegum | SODIUM MONOFLUOROPHOSPHATE | White Glo USA Inc | 1adc752b-2ba8-4d8f-b4f1-5741f864255b | 2026-06-09 | Warnings | M021 |
| BM BIO18 | CALC FLUOR, CALC SULF, SILICEA. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d3c1d6-d0ba-5ea7-e063-6394a90a0294 | 2026-06-09 | Warnings | ETJ7Z6XBU4 |
| XIMONTH Fungi Free Bee Venom Nail Soothing Serum | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 53bab969-8407-6334-e063-6294a90aa5d1 | 2026-06-08 | Warnings | 059QF0KO0R |
| BM Silicea | SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53bb3927-6053-eb3d-e063-6394a90a5ddf | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| Kids Crest Cavity Protection Sparkle Fun | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | df182c22-bbf1-448d-81e8-35cb431d2afc | 2026-06-08 | Warnings | M021 8ZYQ1474W7 |
| Scrofularoforce | RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA | BioActive Nutritional, Inc. | 737cd410-0405-41b0-b7f2-29bb20037849 | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| VAX | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA, | BioActive Nutritional, Inc. | faa4a678-321a-4982-a5d4-01b713e6862d | 2026-06-08 | Warnings | ETJ7Z6XBU4 |
| PEROXICARE | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 55262538-15ce-455c-93b1-bb02b5f81d6b | 2026-06-07 | Warnings | M021 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.