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 |
|---|---|---|---|---|---|---|
| Firstep Firstflush | EYEWASH | Encon Safety Products, Inc. | a44beb26-79ae-98bd-e053-2995a90a9b74 | 2025-12-09 | Warnings | 059QF0KO0R |
| HEB Sensitive Extra Whitening Twin | SODIUM FLUORIDE | HEB | 41d5ae3e-51c1-263b-e063-6394a90a3312 | 2025-12-08 | Warnings | 8ZYQ1474W7 |
| Secale Quartz | SECALE QUARTZ | Uriel Pharmacy Inc. | 1e9f55d7-22d5-4412-ac35-b4400bdf29a0 | 2025-12-08 | Warnings | ETJ7Z6XBU4 |
| Colgate Anticavity Kit | SODIUM MONOFLUOROPHOSPHATE | Ming Fai Industrial (Shenzhen) Co. Ltd | 121decce-c364-4060-87da-0c6a6cd48474 | 2025-12-08 | Warnings | M021 |
| First Class Kit | SODIUM MONOFLUOROPHOSPHATE | American Airlines, Inc. | ba717de8-c3a2-41bf-85a1-aa75f9744d30 | 2025-12-08 | Warnings | M021 |
| United Airlines Business Class Kit | SODIUM MONOFLUOROPHOSPHATE | United Airlines | 94c5e9a4-19f3-4590-9da4-313c75261231 | 2025-12-08 | Warnings | M021 |
| Sodium phenylacetate and Sodium benzoate | SODIUM PHENYLACETATE AND SODIUM BENZOATE | Navinta LLC | d20768fe-4516-483a-a082-ff1df9ad1d99 | 2025-12-06 | Warnings, Adverse reactions | OJ245FE5EU |
| Dr. Jen SuperPaste Nano-Hydroxyapatite | SODIUM FLUORIDE | Dr Jen Natural, LLC | 5f08d994-e458-42b2-aa39-e84fca3acf48 | 2025-12-05 | Warnings | M021 245598 8ZYQ1474W7 |
| Colgate Anticavity Kit | SODIUM MONOFLUOROPHOSPHATE | Ming Fai Industrial (Shenzhen) Co. Ltd | 86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec | 2025-12-05 | Warnings | M021 |
| Dr. Jen SuperPaste Nano-Hydroxyapatite | SODIUM FLUORIDE | Dr Jen Natural, LLC | 8b28b857-9162-4065-b0a0-571efffe9787 | 2025-12-05 | Warnings | M021 245598 8ZYQ1474W7 |
| Dr. Jen SuperPaste Ortho | SODIUM FLUORIDE | Dr Jen Natural, LLC | 9dd248bf-9488-43cd-a041-e8315a05ce5d | 2025-12-04 | Warnings | M021 245598 8ZYQ1474W7 |
| Dr. Jen SuperPaste Perio | SODIUM FLUORIDE | Dr Jen Natural, LLC | 8c7e6d3a-49d9-4098-9d5e-e9792b373574 | 2025-12-04 | Warnings | M021 245598 8ZYQ1474W7 |
| Colgate Total Plaque Cleanse | STANNOUS FLUORIDE | Colgate-Palmolive Company | b2980238-5bcb-467f-9e90-a307938632c2 | 2025-12-03 | Warnings | M021 |
| BM BIO28 ICING SUGAR | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 3e855f3b-c73d-a153-e063-6394a90ad63a | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products Bio28 | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 3e85a931-57f6-2a55-e063-6294a90ac180 | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| Bestmade Natural Products BIO28 | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA: Bestmade Natural Products Micro | 3e46ee90-2c2c-0a70-e063-6294a90a576a | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| Advance White Extreme Whitening Tartar Control | SODIUM FLUORIDE | Church & Dwight Co., Inc. | b539264f-e1ff-440b-af76-84266fe2c0a2 | 2025-12-02 | Warnings | M021 8ZYQ1474W7 |
| BM Silicea | SILICEA | BM Private Limited | 37b0535d-6bcf-2d40-e063-6294a90a2a8e | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| BM Silicea Icing Sugar | SILICEA ICING SUGAR | BM Private Limited | 37c1f61d-dfe4-9dcf-e063-6394a90aceb1 | 2025-12-02 | Warnings | ETJ7Z6XBU4 |
| Sensodyne Pronamel Clinical Enamel Strength Fresh Breath | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | 34a1a32e-3017-f018-e063-6394a90a0230 | 2025-12-01 | Warnings | M021 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.