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 |
|---|---|---|---|---|---|---|
| Rembrandt Deeply White Plus Peroxide | SODIUM MONOFLUOROPHOSPHATE | Ranir LLC | bf7da007-ab9d-4631-bc28-6ca245fd6265 | 2024-11-20 | Warnings | M021 |
| Mammaryplex | ECHINACEA (ANGUSTIFOLIA), MYRRHA, TRIGONELLA FOENUM-GRAECUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, LYMPH (SUIS), SPLEEN (SUIS), BRYONIA (ALBA), CONIUM MACULATUM, LAC CANINUM, LACHESIS MUTUS, SILICEA, BUFO RANA, MAMMARY GLAND (BOVINE) | BioActive Nutritional, Inc. | 2be630bc-9fa6-42a6-b66d-99f91a58b1fa | 2024-11-15 | Warnings | ETJ7Z6XBU4 |
| Acclean Anti-Cavity Sensitivity Relief | POTASSIUM NITRATE, SODIUM FLUORIDE | Henry Schein, Inc. | d5dc57d9-e62d-4b58-a5df-de4e37238dd7 | 2024-11-14 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Colgate Kids Space Jam Mild Bubble Fruit Flavor | SODIUM FLUORIDE | Colgate-Palmolive Company | 54cbfb09-8fd7-ef08-99fd-14fc019c81ff | 2024-11-14 | Warnings | M021 8ZYQ1474W7 |
| Colgate Kids Llama Mild Bubble Fruit Flavor | SODIUM FLUORIDE | Colgate-Palmolive | a7b02cb2-cfb3-7b35-42da-7924d156dcc3 | 2024-11-14 | Warnings | M021 8ZYQ1474W7 |
| Colgate MaxFresh with Mini Breath Clean Mint | SODIUM FLUORIDE | Colgate-Palmolive Company | 82bc1101-84d7-4e21-be9c-870ad88a4b7c | 2024-11-14 | Warnings | M021 8ZYQ1474W7 |
| Acclean Anti-Cavity | SODIUM FLUORIDE | Henry Schein, Inc. | 7db9f10e-8f7b-41b2-a158-21e69e8256eb | 2024-11-14 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Focus | ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM | Deseret Biologicals, Inc. | e014e6b6-a07a-4170-b9af-f477da71597d | 2024-11-13 | Warnings | ETJ7Z6XBU4 |
| Colgate MaxFresh Knockout | SODIUM FLUORIDE | COLGATE PALMOLIVE COMPANY | b6ca4ec7-5087-4693-82b7-199b44d7f931 | 2024-11-13 | Warnings | M021 8ZYQ1474W7 |
| Listerine Smart Rinse Berry Splash | SODIUM FLUORIDE | Kenvue Brands LLC | 5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b | 2024-11-11 | Warnings | M021 8ZYQ1474W7 |
| Listerine Clinical Solutions Teeth Strength Alpine Mint | SODIUM FLUORIDE | Kenvue Brands LLC | 06e2de03-4a58-3de0-e063-6294a90a5857 | 2024-11-11 | Warnings | M021 8ZYQ1474W7 |
| Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash | SODIUM FLUORIDE | Kenvue Brands LLC | ee9a962d-83c7-4b13-bff6-140e48785e8a | 2024-11-11 | Warnings | M021 8ZYQ1474W7 |
| Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield | SODIUM FLUORIDE | Kenvue Brands LLC | d69d2e0d-a3e3-4d95-992d-c0c59172b3a5 | 2024-11-11 | Warnings | M021 8ZYQ1474W7 |
| Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast | SODIUM FLUORIDE | Kenvue Brands LLC | f09f334b-709c-473e-b91e-3f31480ceb90 | 2024-11-11 | Warnings | M021 8ZYQ1474W7 |
| Chronagesic | ALPHA-LIPOICUM ACIDUM, APIOLUM, ARNICA MONTANA, CARTILAGO SUIS, CINNAMOMUM, DULCAMARA, FUNICULUS UMBILICALIS SUIS, NADIDUM, NATRUM OXALACETICUM, PANTOTHENIC ACID, PLACENTA TOTALIS SUIS, PIPER NIGRUM, RHUS TOX, SANGUINARIA CANADENSIS, SULPHUR, SILICEA, SYMPHYTUM OFFICINALE, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 1e340282-dbd9-44d7-9924-807f4099cf0c | 2024-11-08 | Warnings | ETJ7Z6XBU4 |
| Crane Safety Eye Wash | WATER SOLUTION | Crane Safety LLC | 96d8dda9-6cd6-3f68-e053-2995a90a0da2 | 2024-11-08 | Warnings | 059QF0KO0R |
| RUGBY EYE WASH | WATER, PURIFIED | A-S Medication Solutions | 0773e558-2f46-494c-888a-3bc517202b65 | 2024-11-08 | Warnings | 059QF0KO0R |
| BIOTENE Fresh Mint Original | SODIUM FLUORIDE | Haleon US Holdings LLC | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 2024-11-05 | Warnings | 8ZYQ1474W7 |
| Sinus Congestion Headache | ANTIMONIUM TARTARICUM, ASAFOETIDA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, EUPHORBIA PILULIFERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IODIUM, KALI BICHROMICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MUCOSA NASALIS SUIS, PULSATILLA (PRATENSIS), PYROGENIUM, SILICEA, TEUCRIUM MARUM | Liddell Laboratories, Inc. | debc7747-8664-4598-a862-e295188c4fca | 2024-11-04 | Warnings | ETJ7Z6XBU4 |
| Vaccines | ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENS | Liddell Laboratories, Inc. | 6e6e67d4-089e-4775-b4a4-5511953f6e3f | 2024-11-04 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.