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 |
|---|---|---|---|---|---|---|
| Amerfresh Toothpowder | SODIUM FLUORIDE | Yangzhou ONE & ONLY Personal Care Products Co., LTD | 1cacf93e-aa60-4717-87ab-0568a701a4f3 | 2026-03-10 | Warnings | M021 245598 8ZYQ1474W7 |
| Constitutional Enhancer | ACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR. | King Bio Inc. | 448becd7-58aa-40ae-9b4b-39f48a8f13dd | 2026-03-10 | Warnings | ETJ7Z6XBU4 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | a2f9d58b-671b-4427-a971-1fceff5f2323 | 2026-03-09 | Warnings | 8ZYQ1474W7 |
| Anticavity | SODIUM FLUORIDE | CVS Pharmacy, Inc. | a51357df-6d55-4030-a5db-42da7ba54a37 | 2026-03-09 | Warnings, Adverse reactions | M021 8ZYQ1474W7 |
| Vermiclear | GRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUM | Energique, Inc. | f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca | 2026-03-09 | Warnings | ETJ7Z6XBU4 |
| Rain Renewal Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Rain Eye Drops, LLC | bb451b22-c4f6-291d-e053-2a95a90a7801 | 2026-03-06 | Warnings | K679OBS311 |
| 2-Pack Facial Serum | 2-PACK FACIAL SERUM | Guangzhou Ariel Biotech Co., Ltd. | 27c7f645-cfb3-6db1-e063-6394a90a42ff | 2026-03-06 | Warnings | 059QF0KO0R |
| Fluoride | FLUORIDE TOOTHPASTE | McKesson | 4c482e45-0502-a93a-e063-6394a90aa961 | 2026-03-05 | Warnings | M021 |
| Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse | SODIUM FLUORIDE | AMD Medicom | 1da64824-9389-4109-bea9-b91600caf023 | 2026-03-05 | Warnings | 8ZYQ1474W7 |
| PCXX VANILLA ORANGE ONE MINUTE FM | SODIUM FLUORIDE | Ross Healthcare Inc. | 5e816186-519e-606e-e053-2a91aa0a3460 | 2026-03-05 | 8ZYQ1474W7 | |
| PCXX STRAWBERRY APF F | SODIUM FLUORIDE | Ross Healthcare Inc. | 5e859333-b798-2dd3-e053-2991aa0af2e3 | 2026-03-05 | 8ZYQ1474W7 | |
| Osteoplex | EQUISETUM HYEMALE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, MANGANUM MURIATICUM, SYMPHYTUM OFFICINALE, MEDULLA OSSIS SUIS, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA, PARATHYROID GLAND (SUIS), LIGAMENT (SUIS) | BioActive Nutritional, Inc. | 8a7e1397-a387-4f2c-ab4f-7f1a7f1a849b | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
| Respiforce A-HP | ARSENICUM ALBUM, BELLADONNA, IPECACUANHA, KALI CARBONICUM, LOBELIA INFLATA, NATRUM SULPHURICUM, SILICEA | BioActive Nutritional, Inc. | ebf5f0c7-e7a4-45fe-acfd-52c46a8d789c | 2026-03-05 | Warnings | ETJ7Z6XBU4 |
| Sinus Defense 2.0 | LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE | Micro Balance Health Products LLC | 560f84f6-2544-4ba8-8236-a95906eb7d97 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| Snore Control | BROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM. | King Bio Inc. | 704bb574-6c54-49d1-bdae-81ffe0e79d10 | 2026-03-04 | Warnings | ETJ7Z6XBU4 |
| Colgate Maximum Cavity Protection Bubble Fruit Flavor | SODIUM FLUORIDE | Colgate-Palmolive Company | 0a1389f6-cac9-3d58-0744-c488abb0bbcc | 2026-03-03 | Warnings | M021 8ZYQ1474W7 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Amazon.com Services LLC | 349eca80-2e0c-409b-af29-3235fdc0695b | 2026-03-03 | Warnings, Adverse reactions | M021 8ZYQ1474W7 |
| Oral Antivavity | SODIUM FLUORIDE | Amazon.com Services LLC | 03735abc-d1be-4ca0-a497-0a5c5f289402 | 2026-03-03 | Warnings, Adverse reactions | M021 8ZYQ1474W7 |
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | f8036e2e-7541-4922-92b9-0d8319f7b64c | 2026-03-02 | Warnings, Adverse reactions | M021 8ZYQ1474W7 |
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | 64f3d92d-f58c-4bc2-8819-f91492221ddb | 2026-03-02 | Warnings, Adverse reactions | M021 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.