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 |
|---|---|---|---|---|---|---|
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe Mexico, S.A. de C.V. | 3e2e5f52-db54-4635-83a8-a67a683c093c | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| ALPHA SH | SANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARIS | Schwabe North America, Inc. | 94de9ce3-6ee9-4322-bda2-0b4391f09d87 | 2022-03-22 | Warnings | ETJ7Z6XBU4 |
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da807eb3-34a3-61b9-e053-2995a90a0e21 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS | Newton Laboratories, Inc. | da80a5ea-f603-719e-e053-2995a90a9710 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS | Newton Laboratories, Inc. | da81b21a-090a-dabf-e053-2995a90aa05e | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | INFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTIS | Newton Laboratories, Inc. | da821d05-b2f0-3582-e053-2a95a90afe59 | 2022-03-18 | Warnings | ETJ7Z6XBU4 |
| Ear Care | ECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUM | Newton Laboratories, Inc. | da717cf0-54af-c4e2-e053-2995a90ac97c | 2022-03-17 | Warnings | ETJ7Z6XBU4 |
| ACNE HP | CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC | Natural Creations, Inc. | b2368ab6-e233-4473-99fa-86e1fbc2a879 | 2022-02-14 | Warnings | ETJ7Z6XBU4 |
| Iris 60 Second APF | SODIUM FLUORIDE | Benco Dental | 5fa57e34-5827-4d37-a5dc-965750e5be50 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Iris 60 Second APF | SODIUM FLUORIDE | Benco Dental | 6a0f889d-5f27-496f-b830-d778ee867ade | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Iris 60 Second APF | SODIUM FLUORIDE | Benco Dental | 8f5d420b-3348-4002-9a09-b05e8cbb35c9 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Iris 60 Second APF | SODIUM FLUORIDE | Benco Dental | c93f67f5-9833-4a7a-a67a-49a51843e68d | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Iris 60 Second APF | SODIUM FLUORIDE | Benco Dental | d5658bf8-3a13-4d8b-b727-5f1575919571 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart Neutral pH | SODIUM FLUORIDE | Burkhart Dental Supply Inc | a7259222-4ee1-42b2-8beb-3f29a5eb2909 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart Neutral pH | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 0fb4d584-36e8-4db7-b72e-04608580dacd | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 2531ad94-b229-4212-a7a3-f793567a06b6 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 804e7850-1952-4e86-804e-d800ee6e7b50 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 87b3b8b8-780f-492d-bd75-b005edd55baa | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | 79fa0a42-bb69-49db-9997-1679a75bac26 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
| Burkhart | SODIUM FLUORIDE | Burkhart Dental Supply Inc | d7422939-c28e-4bda-b679-81abcc8c36e2 | 2022-02-02 | Warnings | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.