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 |
|---|---|---|---|---|---|---|
| Cool sense Care Plus | SODIUM FLUORIDE | DOCSMEDI Co., Ltd. | ea18ac56-4ef1-4bf0-8c26-6885183fd684 | 2025-01-22 | Warnings | M021 8ZYQ1474W7 |
| DOCTRUST DOUBLEX Tooth | SODIUM FLUORIDE | DOCSMEDI Co., Ltd. | aaf08481-a2ff-48f6-8611-73a469efe1db | 2025-01-22 | Warnings | M021 245598 8ZYQ1474W7 |
| DOCTRUST K Tooth | SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE | DOCSMEDI Co., Ltd. | a02f8865-e7be-4ef4-b09c-dad846639764 | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| Double X CONCENTRATED | CETYLPYRIDINIUM CHLORIDE | DOCSMEDI Co., Ltd. | 411be334-364c-4074-8d0b-8dda332f87de | 2025-01-22 | Warnings | M021 |
| Lemon Quince | LEMON QUINCE | Uriel Pharmacy Inc | 332e4a40-e0f3-11de-8a39-0800200c9a66 | 2025-01-22 | Warnings | ETJ7Z6XBU4 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE | 9055-7588 Quebec Inc. DBA Attitude | d33e3778-ba1d-4560-bafa-74f7ab88c6b5 | 2025-01-20 | Warnings | M021 8ZYQ1474W7 |
| Medics Choice Soothing Eye Wash | PURIFIED WATER | KC Pharmaceuticals, Inc. | 10e49808-161e-f4ec-e063-6294a90a1775 | 2025-01-19 | Warnings | 059QF0KO0R |
| Hydration Complex | BETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALE | Deseret Biologicals, Inc. | f60a2ab8-4146-4995-9bc6-be2660b17540 | 2025-01-16 | Warnings | ETJ7Z6XBU4 |
| AMERFRESH FLUORIDE gel | SODIUM FLUORIDE | Yangzhou ONE & ONLY Personal Care Products Co., LTD | 86279b4d-82e5-45b5-9ba7-94fe3620b850 | 2025-01-16 | Warnings | M021 245598 8ZYQ1474W7 |
| AMERFRESH FLUORIDE | SODIUM FLUORIDE | Yangzhou ONE & ONLY Personal Care Products Co., LTD | 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 | 2025-01-16 | Warnings | M021 245598 8ZYQ1474W7 |
| Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth | SODIUM FLUORIDE | Yangzhou ONE & ONLY Personal Care Products Co., LTD | bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 | 2025-01-16 | Warnings | M021 8ZYQ1474W7 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | c68fd8c7-7ec3-cc3f-e053-2995a90a4395 | 2025-01-16 | Warnings | 8ZYQ1474W7 |
| Medpride | SODIUM MONOFLUOROPHOSPHATE | Shield Line LLC | 9c1b0420-6b57-4914-99fe-df6a494815c3 | 2025-01-16 | Warnings | M021 |
| Lubricating Tears | CARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTION | Reliable 1 Laboritories LLC | 29023a57-eba3-4241-e063-6294a90a7048 | 2025-01-15 | Warnings | K679OBS311 |
| D-34 | OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLA | DNA Labs, Inc. | 607e21a3-2229-48fa-b12c-ebd3130b9996 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-33 | ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINC | DNA Labs, Inc. | 26f9bf6d-6038-42e8-b8c1-6c94ac4929af | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-86 | ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDE | DNA Labs, Inc. | 54fa62d3-c129-4826-a794-f3dcc6b855bf | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-57 | ARSENIC TRIIODIDE, PHOSPHORUS, TEUCRIUM SCORODONIA FLOWERING TOP, SILICON DIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND LYCOPODIUM CLAVATUM SPORE | DNA Labs, Inc. | 81cc16e7-921b-4b57-abeb-c44b9d72e4f3 | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-48 | PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATE | DNA Labs, Inc. | 1d55827f-0ea2-4eda-ae43-7c0723e5708e | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
| D-132 | SILICON DIOXIDE | DNA Labs, Inc. | 3d8e499d-ebe2-45b9-b078-256268c42d4b | 2025-01-13 | Warnings | ETJ7Z6XBU4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.