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 |
|---|---|---|---|---|---|---|
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | cec13e9e-2b99-48a1-9833-c49b18c72614 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 7da82945-3186-40b2-b67e-642bdfa9578a | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | a481e755-6a82-4634-9aa6-bfc7325ccd2c | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | be046466-234e-4742-9bdb-12a13caa6b47 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Tiger Supply Inc APF | SODIUM FLUORIDE | Tiger Supply Inc | 6631aeb7-d892-41dc-97e3-655a8059734f | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 0da6a9de-ad38-4c75-8e88-b68dfc638edc | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 49ca4fc7-6f1a-47e7-9d0c-d015c9a3c202 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Zap APF | SODIUM FLUORIDE | Crosstex International Inc. | 537d2b3f-d7e0-49c9-aaac-680f897b63a5 | 2022-01-20 | Warnings | 8ZYQ1474W7 |
| Sodium Fluoride 5000 ppm Fruit | SODIUM FLUORIDE | Sheffield Pharmaceuticals LLC | a73f72b9-dbcd-4eed-9c20-46a9e8daf859 | 2022-01-19 | Warnings, Adverse reactions | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 492a4a5b-a94d-4928-b0dd-976bb909c476 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 6d3e9f0f-f5e9-44ec-9688-86276d33a8a8 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 615840e4-c108-4d68-b815-fc95ae75539c | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | c8262117-43e6-4771-93ac-618e0f2c8c41 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| PureLife APF | SODIUM FLUORIDE | PureLife Dental | 44b91f76-1b7a-40fc-9c80-e1c915b3d2ca | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Zap Neutral | SODIUM FLUORIDE | Crosstex International Inc. | e1dc8865-a193-44e7-b628-3c4e5d595318 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 6c1907d6-5b22-40fc-b94e-42af7b523902 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | fdf5c2e5-9939-448f-99ec-4de513e32fc1 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | c2d3d7f9-00cf-4d85-af51-71f150cd0289 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 080e7f9d-273e-4f3b-bc84-f7c0dd3cf94c | 2022-01-19 | Warnings | 8ZYQ1474W7 |
| Gelato APF | SODIUM FLUORIDE | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 01d48cbb-fbd6-477f-81ce-1e388718a431 | 2022-01-19 | Warnings | 8ZYQ1474W7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.