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 |
|---|---|---|---|---|---|---|
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 2bf99955-b32e-498e-87dd-a91c8af25948 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | a857af18-8eb8-47dc-bb26-73a321ed643c | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 0dedcb47-7851-4fde-8a46-7d1155839a57 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 2ba4a209-c56f-4cbe-8727-d428d2090b08 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 129ecbf8-17c8-4259-a4ca-7c0a09298bb0 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 852de04d-f608-4f7f-b76b-25a29967c090 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | cec13e9e-2b99-48a1-9833-c49b18c72614 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 7da82945-3186-40b2-b67e-642bdfa9578a | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | a481e755-6a82-4634-9aa6-bfc7325ccd2c | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | be046466-234e-4742-9bdb-12a13caa6b47 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 6631aeb7-d892-41dc-97e3-655a8059734f | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 0da6a9de-ad38-4c75-8e88-b68dfc638edc | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 49ca4fc7-6f1a-47e7-9d0c-d015c9a3c202 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 537d2b3f-d7e0-49c9-aaac-680f897b63a5 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Sodium Fluoride 5000 ppm Fruit | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | a73f72b9-dbcd-4eed-9c20-46a9e8daf859 | 2022-01-19 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 492a4a5b-a94d-4928-b0dd-976bb909c476 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 6d3e9f0f-f5e9-44ec-9688-86276d33a8a8 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 615840e4-c108-4d68-b815-fc95ae75539c | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | c8262117-43e6-4771-93ac-618e0f2c8c41 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 44b91f76-1b7a-40fc-9c80-e1c915b3d2ca | 2022-01-19 | Warnings | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.