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 |
|---|---|---|---|---|---|---|
| PCXX RASPBERRY NEUTRAL GL | SODIUM FLUORIDE | Ross Healthcare Inc. | 8296928e-8e4c-0e31-e053-2a91aa0ad694 | 2025-08-02 | 8ZYQ1474W7 | |
| Medics Choice Fresh and Soothe | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN | KC Pharmaceuticals, Inc. | 3bc03d54-6b31-5921-e063-6294a90af599 | 2025-08-01 | Warnings | K679OBS311 |
| Sodium Fluoride Chewable | SODIUM FLUORIDE | Bryant Ranch Prepack | 81497d2c-5ca8-4df6-8ddc-3abe23c8b922 | 2025-07-30 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Ipana Wintergreen Fluoride | SODIUM MONOFLUOROPHOSPHATE | Maxill Inc. | 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0 | 2025-07-28 | Warnings | M021 |
| Ipana Bucky Beaver Bubble Gum Childrens Fluoride | SODIUM MONOFLUOROPHOSPHATE | Maxill Inc | e7aa2a8d-7140-4718-bf69-917bb50d32c7 | 2025-07-28 | Warnings | M021 |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 985a3341-0fe0-1dd6-e053-2a95a90ad2c5 | 2025-07-25 | Warnings | ETJ7Z6XBU4 |
| SILICA MARINA | SILICON DIOXIDE | Boiron | 3aada26e-6a8e-f545-e063-6394a90a9f80 | 2025-07-24 | ETJ7Z6XBU4 | |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1b4e96-c96f-6424-e053-2991aa0aef30 | 2025-07-24 | Warnings | ETJ7Z6XBU4 |
| Cell Salts | CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA | Newton Laboratories, Inc. | 7a1a9ef9-9a54-5f94-e053-2a91aa0ab477 | 2025-07-24 | Warnings | ETJ7Z6XBU4 |
| Dubai Chocolate Flavor | ANTICAVITY TOOTHPASTE | SuperMouth, LLC. | d1615a53-ecfc-49d1-b836-f7643b9d2660 | 2025-07-24 | Warnings | M021 8ZYQ1474W7 |
| ACT Restoring Anticavity Fluoride Mint Burst | SODIUM FLUORIDE | Chattem, Inc. | 0c7ede82-3b28-40ae-8dfd-cec58825f938 | 2025-07-23 | Warnings | M021 8ZYQ1474W7 |
| Dubai Chocolate Fluoride Mouthwash | ANTICAVITY MOUTHWASH | SuperMouth, LLC. | ef81a983-64c1-4913-9235-25451f023852 | 2025-07-23 | Warnings | M021 8ZYQ1474W7 |
| ACT Restoring Anticavity Fluoride Cool Mint | SODIUM FLUORIDE | Chattem, Inc. | 3409a749-4a1a-4950-8c21-364d1b977af7 | 2025-07-22 | Warnings | M021 8ZYQ1474W7 |
| Act Total Care Anticavity Fluoride Fresh Mint | SODIUM FLUORIDE | Chattem, Inc. | dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 | 2025-07-22 | Warnings | M021 8ZYQ1474W7 |
| PCXX PEPPERMINT APF F | SODIUM FLUORIDE | Ross Healthcare Inc. | 5e86783c-414a-5f46-e053-2991aa0abb3b | 2025-07-21 | 8ZYQ1474W7 | |
| Focus Tears PF | CARBOXYMETHYLCELLULOSE SODIUM | Covalent Medical | 772c7070-82ff-4371-b071-940ff91372c6 | 2025-07-17 | Warnings | K679OBS311 |
| Aller-Chord F | ACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE. | Energetix Corporation | ff4eb7b2-8272-4bd3-99a9-7e589b30d59a | 2025-07-15 | Warnings | ETJ7Z6XBU4 |
| DENTAL-CHORD | ACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUM | Energetix Corporation | 6c9ba926-7c35-49fd-94d8-988ca0bb772c | 2025-07-15 | Warnings | 8ZYQ1474W7 ETJ7Z6XBU4 |
| Brush Buddies Oral Rinse Sparkle Mint | SODIUM FLUORIDE | ASHTEL STUDIOS, INC | fe2c06fc-6497-4888-877f-1a88e02fad20 | 2025-07-15 | Warnings | M021 8ZYQ1474W7 |
| evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE | SODIUM FLUORIDE | Ashtel Studios, Inc. | 1620c7fa-2af6-4462-af5d-9e122942788a | 2025-07-15 | Warnings | M021 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.