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 |
|---|---|---|---|---|---|---|
| Rain Renewal Eye Drops | CARBOXYMETHYLCELLULOSE SODIUM | Rain Eye Drops, LLC | af7a5768-7d1d-3d93-e053-2a95a90a38f6 | 2024-12-29 | Warnings | K679OBS311 |
| TruGuard 5000 | SODIUM FLUORIDE TOOTHPASTE | The Atlanta Dental Supply Company DBA Advanced Dental Products | 3b8efdcf-5beb-46c2-b118-64940a7fc74b | 2024-12-28 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Morning Fresh | SODIUM FLUORIDE | Dynarex Corporation | 1d0457d7-0228-4ea3-9755-73bacd2201e6 | 2024-12-27 | Warnings | M021 |
| Bubble Fresh Toothpaste, with Fluoride | BUBBLE FRESH TOOTHPASTE, WITH FLUORIDE | Dynarex Corporation | 2a2f5ed9-31ec-f6c8-e063-6394a90a44d6 | 2024-12-26 | Warnings | M021 245598 8ZYQ1474W7 |
| Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVOR | SODIUM FLUORIDE | Ashtel Studios, Inc. | b3006c29-1f7f-4d9f-ab46-5a36df1a0471 | 2024-12-25 | Warnings | M021 8ZYQ1474W7 |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUM | Energique, Inc. | f3db63df-62a4-48d6-92e7-94e4a5701552 | 2024-12-20 | Warnings | 368GB5141J |
| Listerine Total Care Zero Alcohol Anticavity Fresh Mint | SODIUM FLUORIDE | Kenvue Brands LLC | 4b594a6e-db1d-443b-bfa7-23ee15749f47 | 2024-12-19 | Warnings | M021 8ZYQ1474W7 |
| Trace Mineral Cord | ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM, | Energique, Inc. | 902dd68d-5ce1-481e-8938-6487dcc68dfc | 2024-12-19 | Warnings | ETJ7Z6XBU4 |
| NewYork-Presbyterian Amenity | SODIUM MONOFLUOROPHOSPATE | ASP Global, LLc | 4b307471-445d-4c51-a499-d074a8172f20 | 2024-12-17 | Warnings | M021 |
| Household Detox | ALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLON | Deseret Biologicals, Inc. | 7f79058a-c35a-429a-be3c-4cff1d657087 | 2024-12-13 | Warnings | K679OBS311 |
| Fendall Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | afda6fc3-7615-b0be-e053-2995a90a6208 | 2024-12-10 | Warnings | 059QF0KO0R |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive (Thailand) Limited - Branch | 5bc0b430-6f68-4e52-a1da-de19136eaeac | 2024-12-09 | Warnings | M021 |
| CURODONT REPAIR FLUORIDE PLUS | SODIUM FLUORIDE | CREDENTIS AG | 03ec09f9-4281-9ccb-e063-6294a90aadd8 | 2024-12-01 | Warnings | M021 8ZYQ1474W7 |
| CURODONT PROTECT | STANNOUS FLUORIDE | CREDENTIS AG | 03ec591c-68c3-a380-e063-6394a90a131a | 2024-12-01 | Warnings | M021 |
| ACT Kids Anticavity Fluoride Bubble Gum Blowout | SODIUM FLUORIDE | Chattem, Inc. | 61f3a3e6-645b-4368-b1d5-7de1fc14542e | 2024-12-01 | Warnings | M021 8ZYQ1474W7 |
| Geovita | CEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEA | RUBIMED AG | 0fcb5c06-d414-456c-a0ef-28e14018a781 | 2024-11-29 | Warnings | ETJ7Z6XBU4 |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d41602-9dcb-eaa8-e063-6394a90a7cfa | 2024-11-26 | Warnings | ETJ7Z6XBU4 |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | 2024-11-26 | Warnings | ETJ7Z6XBU4 |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d5997b-1cae-41c2-e063-6394a90ac74a | 2024-11-26 | Warnings | ETJ7Z6XBU4 |
| SparkleFresh Flouride Toothpaste | SODIUM MONOFLUOROPHOSPHATE | Medline Industries, LP | 1565528b-89f2-4c97-b294-15b6ebd3f80e | 2024-11-26 | Warnings | M021 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.