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 |
|---|---|---|---|---|---|---|
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 192c4e46-0bfd-4f48-901c-ce4f09f91e3e | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 5ef9652f-4d99-493d-97ee-9807c6f39182 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 8d1997c0-4f61-46b5-954e-620d521d3fba | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 9cbfd85a-a930-4a4b-a362-b142f6312c59 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 26b1f8ab-3540-4c3f-95ab-e9cb1c5cee97 | 2022-01-25 | Warnings | 8ZYQ1474W7 |
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | acb56376-a6da-45e0-9896-a890137d6c2d | 2022-01-24 | Warnings | 8ZYQ1474W7 |
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | b4b69649-62f9-47bf-9d93-29d06c6fb652 | 2022-01-24 | Warnings | 8ZYQ1474W7 |
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | 90a5acb3-f8cb-1e82-e053-2995a90a4e97 | 2022-01-24 | Warnings | 8ZYQ1474W7 |
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | 90a59a06-d020-1bab-e053-2995a90a57aa | 2022-01-24 | Warnings | 8ZYQ1474W7 |
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | 90a3cb10-c205-278d-e053-2a95a90a848e | 2022-01-24 | Warnings | 8ZYQ1474W7 |
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | 90a5f14b-97e8-7757-e053-2a95a90a3d97 | 2022-01-24 | Warnings | 8ZYQ1474W7 |
| 60 Second Fluoride Gel | SODIUM FLUORIDE | Darby Dental Supply, LLC | 90a2e268-bee8-498d-e053-2995a90ad52b | 2022-01-24 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 898c0b7f-7ebb-4dba-9ebf-9d1e4805a8c6 | 2022-01-21 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | ec50b003-cf61-4f66-bb62-f779e48363c2 | 2022-01-21 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | f05390e2-9a0a-46fc-9da4-ad2651487b0a | 2022-01-21 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 57d70fbe-a0cc-4aaa-b2c7-b9843455d1d9 | 2022-01-21 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 1c5e2cf3-99ef-4737-941e-bc7fb90259e4 | 2022-01-21 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 9cc82e34-9b2d-4815-b9ff-99d2292faff2 | 2022-01-21 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 26f3c9a5-7181-4d82-8fa2-21cebd090620 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.