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 |
|---|---|---|---|---|---|---|
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Deseret Biologicals, Inc. | 6d934960-63c6-4536-bde3-38c26f8083dc | 2024-02-06 | Warnings | ETJ7Z6XBU4 |
| TheraBreath Fresh Breath Anticavity Mild Mint | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 19ce5324-7d8d-4d70-ad9b-238f7e612eac | 2024-02-06 | Warnings | M021 8ZYQ1474W7 |
| Nature Mint Anticavity | SODIUM MONOFLUOROPHOSPHATE | Bob Barker Company Inc. | 916891d3-5234-46a8-a492-21a31f36a852 | 2024-02-02 | Warnings | M021 |
| Floriva | VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDE | BonGeo Pharmaceuticals, Inc. | 34b2924f-d220-4344-8cdd-e7dda54061c2 | 2024-02-02 | Warnings | 8ZYQ1474W7 |
| Sterile Water | STERILE WATER | Chartwell RX, LLC | 3681eeaa-807a-47ca-9fbc-61c2b682800a | 2024-02-01 | 059QF0KO0R | |
| Floriva | VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDE | BonGeo Pharmaceuticals, Inc. | 768502e2-541f-4de8-ac68-3ab47c1f436d | 2024-02-01 | Warnings | 8ZYQ1474W7 |
| Floriva | CHOLECALCIFEROL AND SODIUM FLUORIDE | BonGeo Pharmaceuticals, Inc. | 54eeeeda-9314-4b7c-9efc-0bedfffb91b6 | 2024-02-01 | Warnings | 8ZYQ1474W7 |
| Floriva | VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDE | BonGeo Pharmaceuticals, Inc. | 3d5fbe3a-a95b-4688-a96e-b34e6e1e868a | 2024-02-01 | Warnings | 8ZYQ1474W7 |
| Treatment Rinse Mint | ANTICARIES | DENTAL ALLIANCE HOLDINGS LLC | f1255065-b7c3-4eb6-e053-2995a90afcdb | 2024-01-31 | Warnings | M021 8ZYQ1474W7 |
| Maintenance Rinse Mint | ANTICARIES | Dental Alliance Holdings LLC | f1273510-aa83-3ef9-e053-2a95a90aea27 | 2024-01-31 | Warnings | M021 8ZYQ1474W7 |
| Sterile Water | WATER | A-S Medication Solutions | dba87371-31d2-47c2-ab83-89aabce4b184 | 2024-01-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Silicea | SILICON DIOXIDE | SEVENE USA | 0805d866-ce1a-4f54-8a44-83d4902e8c0d | 2024-01-30 | Warnings | ETJ7Z6XBU4 |
| ATOMY PROPOLIS TOOTHPAS TE 50G | SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE | ATOMY CO., LTD. | 98d839e3-a1aa-c83d-e053-2995a90a7e79 | 2024-01-30 | Warnings | M021 8ZYQ1474W7 |
| ATOMY PROPOLIS TOOTHPAS TE 200G | SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE | ATOMY CO., LTD. | 98aebbec-aec0-1478-e053-2a95a90a03ea | 2024-01-30 | Warnings | M021 8ZYQ1474W7 |
| SENSODYNE PRONAMEL Daily Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 2024-01-24 | Warnings | 8ZYQ1474W7 |
| Toms Childrens Anticavity Mouthwash Silly Strawberry | SODIUM FLUORIDE | Tom's of Maine, Inc. | 998c6f35-20f4-4cb8-bc48-6aa39e61481a | 2024-01-18 | Warnings | M021 8ZYQ1474W7 |
| Gel-Kam Fruit and Berry | STANNOUS FLUORIDE | Colgate Oral Pharmaceuticals, Inc. | 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c | 2024-01-18 | Warnings | M021 |
| Sleep Tight | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Dr. Donna Restivo DC | b5955fbc-71f8-4fe0-9df0-42f337ab9c7d | 2024-01-18 | Warnings | ETJ7Z6XBU4 |
| Peppermint Twist | FLUORIDE | Caldwell Health LLC | 4b28cdd1-0dba-42f5-a9e8-06d9e75b2396 | 2024-01-17 | Warnings | 8ZYQ1474W7 |
| The Natural Dentist Groovy Grape | FLUORIDE | Caldwell Consumer Health LLC | 087abbed-1f58-4b45-a76b-a950fa81c18c | 2024-01-16 | Warnings | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.