NDC 64778-0446-01 - Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse
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
- 64778-0446
- Requested NDC
- 64778-0446-01
- Package NDCs from labels
- 64778-0446-1, 64778-0446-3, 64778-0446-01
- Manufacturer
- AMD Medicom
- Effective date
- 2026-03-05
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse - AMD Medicom | AMD Medicom | 2026-03-05 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64778-0446-1 | Denti-Care Denti-RinseNeutral Sodium Fluoride Oral Rinse | 1900 mL in 1 BOTTLE, PUMP | LIQUID | 1900 | 8 | |
| 64778-0446-3 | Denti-Care Denti-RinseNeutral Sodium Fluoride Oral Rinse | 12 in 1 CASE | LIQUID | 12 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64778-0446 | DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AMD MEDICOM] | 7 | Current NDC, Legacy NDC, 2 package rows | 20210128_1da64824-9389-4109-bea9-b91600caf023.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| sodium fluoride | ACTIVE INGREDIENT | 8ZYQ1474W7 | DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AR MEDICOM INC] | 1 | |
| fluoride ion | ACTIVE MOIETY | Q80VPU408O | DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AR MEDICOM INC] | 1 |
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 |
|---|---|---|---|---|---|---|
| Quflora Pediatric | VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDE | CarWin Pharmaceutical Associates, LLC | b8e08798-d8bb-4616-996b-a2c07a5d730a | 2024-01-10 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Colgate MaxFresh with Mini Breath Cool Mint | SODIUM FLUORIDE | Colgate-Palmolive Company | 51abd6bc-7a3d-4b0e-a810-af9e94926438 | 2024-01-09 | Warnings | 8ZYQ1474W7 |
| Colgate Enamel Strength Mouthwash | SODIUM FLUORIDE | Colgate-Palmolive - do not use | f0cca38b-c0a3-4788-8cca-727a5684c16b | 2024-01-09 | Warnings | 8ZYQ1474W7 |
| N01 PROTOMER | ADRENALINUM, ARGENTUM NITRICUM, ARNICA MONTANA, AURUM METALLICUM, AVENA SATIVA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, CHININUM ARSENICOSUM, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, NATRUM FLUORATUM, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARSAPARILLA, SILICEA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, ZINCUM VALERIANICUM | Apex Energetics Inc. | bfc8e049-2f62-31c4-e053-2a95a90a6e16 | 2024-01-08 | Warnings | 8ZYQ1474W7 |
| PerCara Kids Bubble Gum | SODIUM FLUORIDE | LEC Custom Products, Inc. | be3a7272-acfb-7d14-e053-2995a90a9420 | 2024-01-01 | Warnings | 8ZYQ1474W7 |
| Orajel Complete Protection | SODIUM FLUORIDE | Church & Dwight Co., Inc. | daebd16f-d278-446d-8b7a-33add5a74fdd | 2023-12-19 | Warnings | 8ZYQ1474W7 |
| Orajel Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | Church & Dwight Co., Inc. | 7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb | 2023-12-19 | Warnings | 8ZYQ1474W7 |
| NEUTRAMAXX 5000 TCP | SODIUM FLUORIDE | Massco Dental A Division of Dunagin Pharmaceuticals | f47cb584-eb8a-4297-ba32-5f435e85aacb | 2023-12-17 | Warnings | 8ZYQ1474W7 |
| ORTHO GUARD | SODIUM FLUORIDE | Massco Dental A Division of Dunagin Pharmaceuticals | 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd | 2023-12-17 | Warnings | 8ZYQ1474W7 |
| NEUTRAMAXX 5000 PLUS TURBO | SODIUM FLUORIDE | Massco Dental A Division of Dunagin Pharmaceuticals | 3c7584f1-b652-4d82-99e7-10da0ee242c1 | 2023-12-17 | Warnings | 8ZYQ1474W7 |
| NEUTRA MAXX 5000 | SODIUM FLUORIDE | Massco Dental A Division of Dunagin Pharmaceuticals | fcbe6baa-2827-49df-9316-42cc86595203 | 2023-12-17 | Warnings | 8ZYQ1474W7 |
| Moon Whitening Gel Anticavity | SODIUM FLUORIDE | Moon Oral Care, LLC | 0c556a29-a697-3a66-e063-6394a90abfee | 2023-12-12 | Warnings | 8ZYQ1474W7 |
| Moon Charcoal Whitening Anticavity | SODIUM FLUORIDE | Moon Oral Care, LLC | 0c55f7b3-fea1-58f3-e063-6394a90a3bde | 2023-12-12 | Warnings | 8ZYQ1474W7 |
| Pearl White | POTASSIUM NITRATE, SODIUM FLUORIDE | Beyond International Inc. | 51c79544-9536-5863-e054-00144ff8d46c | 2023-11-28 | Warnings | 8ZYQ1474W7 |
| Beyond Activated Coconut Charcoal and Sea Salt | SODIUM FLUORIDE | Beyond International Inc | d075fa15-7309-0c10-e053-2995a90a7c95 | 2023-11-28 | Warnings | 8ZYQ1474W7 |
| Hello Vitamin C Whitening | SODIUM FLUORIDE | Colgate-Palmolive Company | 38a0276e-910c-527d-1736-65928b9d4ca4 | 2023-11-20 | Warnings | 8ZYQ1474W7 |
| POP Feeling Peachy | SODIUM FLUORIDE | LG H&H CO., LTD. | 0abaf99b-9547-46ae-e063-6394a90a6c15 | 2023-11-17 | Warnings | 8ZYQ1474W7 |
| UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE | POTASSIUM NITRATE AND SODIUM FLUORIDE | Universal Distribution Center LLC | fcf59439-7e06-4129-a89f-cdeecdf8d488 | 2023-11-17 | Warnings | 8ZYQ1474W7 |
| UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE | SODIUM FLUORIDE | Universal Distribution Center LLC | 3411924d-1002-460c-83e8-c0c7fbff9ad1 | 2023-11-16 | Warnings | 8ZYQ1474W7 |
| Denta 5000 Plus Sensitive | SODIUM FLUORIDE AND POTASSIUM NITRATE | Rising Pharma Holdings, Inc. | 585fb1f5-8c08-43bd-8be4-64adc065d9a2 | 2023-11-09 | Warnings, Adverse reactions | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.