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 |
|---|---|---|---|---|---|---|
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, inc. | d22afac7-45d6-467e-951a-e7c241b9180d | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, inc. | 4828b482-486f-4105-bed0-3fe2ddbbddb1 | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, Inc. | 8987b447-3fa3-4f52-aecc-80e44c981aaa | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Neutral | SODIUM FLUORIDE | Dharma Research, inc. | 8191554f-adb6-4ba9-aa80-0a9bb65193ec | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| Ionite APF Foam | SODIUM FLUORIDE | Dharma Research, inc. | ddd34623-cb79-4fa7-bd01-19122470b63d | 2020-10-27 | Warnings | 8ZYQ1474W7 |
| FluoriMax 5000 | 1.1% SODIUM FLUORIDE TOOTHPASTE | Elevate Oral Care | ae45ae2d-a21f-0a05-e053-2995a90a4d5e | 2020-09-01 | Warnings | 8ZYQ1474W7 |
| FluoriMax 5000 Sensitive | 1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE | Elevate Oral Care | ae32b0a2-e42f-6a56-e053-2a95a90a0b00 | 2020-08-31 | Warnings | 8ZYQ1474W7 |
| Sodium Fluoride 5000 ppm Sensitive | SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5% | Sheffield Pharmaceuticals LLC | 02f4cf0b-188c-4522-b759-ffe4a9d150e8 | 2020-04-01 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| PreviDent 5000 Sensitive | SODIUM FLUORIDE AND POTASSIUM NITRATE | Colgate Oral Pharmaceuticals, Inc. | b028cfff-4946-49e8-b8bb-197ab99d0d35 | 2019-12-09 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Colgate Max Fresh Cool Mint | SODIUM FLUORIDE | Mission Hills S.A de C.V | d142e43f-415a-41c5-a7db-8b18a039a323 | 2019-04-09 | Warnings | 8ZYQ1474W7 |
| KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT | SODIUM FLUORIDE | DMG AMERICA, LLC | 21fa26f2-0162-4044-aec0-d5360be3f3e0 | 2019-03-28 | Warnings | 8ZYQ1474W7 |
| FLUORIDEX | SODIUM FLUORIDE | DEN-MAT HOLDINGS, LLC. | 5fd60635-4b66-15e3-e053-2991aa0ab23a | 2019-02-28 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Pro-Den Rx | SODIUM FLUORIDE | Den-mat Holdings, Llc | e39b19f7-2b3e-4c77-9544-623ebad84870 | 2019-02-28 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| FLUORIDEX | SODIUM FLUORIDE | DEN-MAT HOLDINGS, LLC. | 6014c330-3698-027c-e053-2a91aa0a64e5 | 2019-02-28 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Pro-Den Rx | SODIUM FLUORIDE | Den-Mat Holdings, Llc | ba020e07-ad41-4419-a503-f1245131b7d2 | 2018-04-17 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Sensitive Tooth Polish | POTASSIUM NITRATE AND SODIUM FLUORIDE | Melaleuca, Inc. | 689349e4-3980-a0e4-e053-2991aa0a9ef5 | 2018-03-29 | Warnings | 8ZYQ1474W7 |
| SF | 1.1% SODIUM FLUORIDE | Cypress Pharmaceutical, Inc. | b7c0a768-7e8a-40b9-876f-b86d3dc5e848 | 2016-07-06 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| SF 5000 Plus | 1.1% SODIUM FLUORIDE PRESCRIPTION DENTAL CREAM | Cypress Pharmaceutical, Inc. | fa625ece-d873-491a-8d45-2833b64e5425 | 2016-07-01 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Ionite H | SODIUM FLUORIDE, POTASSIUM NITRATE | Dharma Research, Inc. | 54c1a27c-5936-4ee2-a419-3891d3df9745 | 2015-08-02 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| Ionite H | SODIUM FLUORIDE, POTASSIUM NITRATE | Dharma Research, Inc. | 642fec99-c5c5-4ef2-986e-5b5f7cf460de | 2015-08-02 | Warnings, Adverse reactions | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.