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 |
|---|---|---|---|---|---|---|
| Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination | CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA | OHM PHARMA INC. | 044a7174-f7a3-490f-9cad-01f2665d7575 | 2022-12-02 | Warnings | ETJ7Z6XBU4 |
| Refresh Digital PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | 97e83e68-6374-4df4-93f6-d707fc32748d | 2022-11-28 | Warnings | K679OBS311 |
| Refresh Digital | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81 | 2022-11-28 | Warnings | K679OBS311 |
| 4 Kids Cold and Mucus Nighttime | EUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFUR | Hyland's Inc. | 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| 4 Kids Complete Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | ef39fe3d-a42d-4baa-9199-91f664feb432 | 2022-11-21 | Warnings | ETJ7Z6XBU4 |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| REFRESH OPTIVE | CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN | Allergan, Inc. | 7f8d88af-fd3b-4138-af61-f24c59ccebd7 | 2022-09-23 | Warnings | K679OBS311 |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | ebd0839e-2e1d-4e0e-986c-19f1f5c76358 | 2022-09-15 | Warnings | K679OBS311 |
| REFRESH OPTIVE Advanced | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80 | Allergan, Inc. | aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0 | 2022-09-01 | Warnings | K679OBS311 |
| Hendel Periodontal and Tooth Pain Relief | SODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDE | MediNatura Inc | f34e9f77-69fd-4c7f-9eea-2d721a4d27fb | 2022-08-22 | Warnings | ETJ7Z6XBU4 |
| Natrum Fluoratum | NATRUM FLUORATUM | Hahnemann Laboratories, INC. | e54bdb28-890b-4869-e053-2995a90a8efd | 2022-08-02 | 8ZYQ1474W7 | |
| REFRESH TEARS | CARBOXYMETHYLCELLULOSE SODIUM | Allergan, Inc. | 329d1fe0-4432-4565-b7b1-65666bd86526 | 2022-06-30 | Warnings | K679OBS311 |
| REFRESH Optive Mega-3 | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80 | Allergan, Inc. | c5f2b3f2-2071-45bd-a010-67f848bc0233 | 2022-06-30 | Warnings | K679OBS311 |
| REFRESH PLUS | CARBOXYMETHYLCELLULOSE SODIUM | Allergan, Inc. | 0f6a4b4b-cde6-4518-84b5-ce997f1154a7 | 2022-06-28 | Warnings | K679OBS311 |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Addiclenz | BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM | Deseret Biologicals, Inc. | e39235ea-2a2f-44a7-92d6-fb1d428ebabd | 2022-05-12 | Warnings | OJ245FE5EU |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.