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 |
|---|---|---|---|---|---|---|
| Prid | ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR | Hyland's Inc. | 49689eeb-7790-07f1-e063-6294a90a2df2 | 2026-07-16 | Warnings | ETJ7Z6XBU4 |
| COLGATE KPOP DEMON HUNTERS BUBBLE POP | SODIUM FLUORIDE | Colgate-Palmolive Company | bf465181-01e9-44ca-91f8-03110a606774 | 2026-07-16 | Warnings | M021 8ZYQ1474W7 |
| Colgate Minions Mild Bubble Fruit Fluoride | SODIUM FLUORIDE | Colgate-Palmolive Company | 16634b99-f305-48bf-ac54-a9f53797a9e5 | 2026-07-16 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up Holiday mint | SODIUM FLUORIDE | Dabur India Limited | 56aaa9f5-7eac-11d9-e063-6294a90af3a8 | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up pepper mint | SODIUM FLUORIDE | Dabur India Limited | 56aaba60-523e-6ac7-e063-6394a90a2756 | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Freshen-up Matcha Mint | SODIUM FLUORIDE | Dabur India Limited | 56aac050-73e7-298c-e063-6294a90a26eb | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up twisted peppermint | SODIUM FLUORIDE | Dabur India Limited | 56aac7a7-c086-2fa5-e063-6294a90aa959 | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up Vanilla Mint | SODIUM FLUORIDE | Dabur India Limited | 56aad223-db88-7cf6-e063-6394a90a6b72 | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up | SODIUM FLUORIDE | MKJ BRANDS LLC | 2dcd4816-caa5-c006-e063-6394a90ac487 | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up | SODIUM FLUORIDE | DABUR INDIA LIMITED | 56acecd2-6966-2ee4-e063-6394a90a356f | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Leg Cramps PM | OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR | Hyland's Inc. | b0574a7e-88fa-417e-b6d5-60ced59eba47 | 2026-07-15 | Warnings | ETJ7Z6XBU4 |
| Colgate Max Fresh Advanced Whitening | SODIUM FLUORIDE | Colgate-Palmolive Company | 01c07c25-2748-4d90-9505-094e2c977c9c | 2026-07-15 | Warnings | M021 8ZYQ1474W7 |
| Crest Strawberry | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 7d51c67b-7409-e5a7-e053-2a91aa0a81fa | 2026-07-14 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up | SODIUM FLUORIDE, POTASSIUM NITRATE | MKJ BRANDS LLC | 476f453b-9215-0a11-e063-6294a90a5cd4 | 2026-07-14 | Warnings | M021 |
| Freshen Up Vanilla Mint | SODIUM FLUORIDE | MKJ BRANDS LLC | 525662da-42be-eaa6-e063-6294a90af110 | 2026-07-14 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up twisted peppermint | SODIUM FLUORIDE | MKJ BRANDS LLC | 526acbdd-6531-692d-e063-6394a90ab9f1 | 2026-07-14 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up chai latte mint | SODIUM FLUORIDE | MKJ BRANDS LLC | 52e364f9-113a-df4e-e063-6294a90a263b | 2026-07-14 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up Holiday mint | SODIUM FLUORIDE | MKJ BRANDS LLC | 5257c409-d379-8c48-e063-6294a90acda9 | 2026-07-14 | Warnings | M021 8ZYQ1474W7 |
| Freshen-up Matcha Mint | SODIUM FLUORIDE | MKJ BRANDS LLC | 52bbc6d9-17ab-851a-e063-6394a90ab4bf | 2026-07-14 | Warnings | M021 8ZYQ1474W7 |
| Freshen Up pepper mint | SODIUM FLUORIDE | MKJ BRANDS LLC | 5259bc45-85da-b17b-e063-6294a90a7919 | 2026-07-14 | Warnings | M021 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.