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 |
|---|---|---|---|---|---|---|
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | b1d799c6-e483-44fd-b07c-94ca2ee239ef | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | c33e0e2e-7c68-4908-8bd4-6a3669c8774b | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT | SODIUM FLUORIDE | DMG AMERICA, LLC | b83c62be-8e9d-4fa2-aa10-d34c88bf2387 | 2021-10-01 | Warnings | 8ZYQ1474W7 |
| KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINT | SODIUM FLUORIDE | DMG AMERICA, LLC | 427f25e6-e50a-407a-a6f0-512123e381e4 | 2021-10-01 | Warnings | 8ZYQ1474W7 |
| Wentworth Alcohol Free | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | 5ed816ef-20bc-49ac-9202-8fac1edac579 | 2021-03-23 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Sodium Fluoride 5000 ppm Dry Mouth | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | cbc67f03-55c4-4781-ba37-87c737b60282 | 2021-03-02 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, Inc. | ab9b07ad-f6b2-4289-bec4-fec58270dc97 | 2021-02-20 | Warnings | 8ZYQ1474W7 |
| Avant | SODIUM FLUORIDE | Dharma Research, Inc. | 4749dce1-c0b9-4737-8a30-85cd58aba21b | 2021-01-25 | Warnings, Adverse reactions | 251960 8ZYQ1474W7 |
| Avant | SODIUM FLUORIDE | Dharma Research, Inc. | 184bbe52-3909-45f6-b4d0-fe7849fabc1c | 2021-01-25 | Warnings, Adverse reactions | 251960 8ZYQ1474W7 |
| Sodium Fluoride 5000 ppm Enamel Protect | SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5% | Sheffield Pharmaceuticals LLC | 83dfdead-4f71-404e-90ae-dbd6849c7cf1 | 2021-01-04 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Ionite APF Neutral | SODIUM FLUORIDE | Dharma Research, inc. | ad7a660b-274c-417e-bdf3-1d5addf06ad1 | 2020-11-18 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | 8ff1b377-0535-4548-a109-f9f1a43b85b7 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | e6c31330-43e0-4d32-af54-ff852af39cab | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | bc9664df-c4eb-4d29-b1c0-4d4dff6a75e4 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | b8b7f9b8-ff11-4a76-ab36-7822c15e1892 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | e1797adf-4665-4322-a3aa-dd2da9dcd3a8 | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | ce34c159-34cd-47c7-937f-743b3309742b | 2020-11-16 | Warnings | 8ZYQ1474W7 |
| Ionite APF | SODIUM FLUORIDE | Dharma Research, inc. | 503ca71a-f50c-4406-b925-5b6ac36a9212 | 2020-11-15 | Warnings | 8ZYQ1474W7 |
| Ionite R | SODIUM FLUORIDE | Dharma Research, Inc. | 1009afc7-6e9d-417f-a702-f8a941e08484 | 2020-11-06 | Warnings, Adverse reactions | 251960 8ZYQ1474W7 |
| Ionite R | SODIUM FLUORIDE | Dharma Research, Inc. | 0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a5 | 2020-11-06 | Warnings, Adverse reactions | 251960 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.