FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse - AMD MedicomAMD Medicom2026-03-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64778-0446-1Denti-Care Denti-RinseNeutral Sodium Fluoride Oral Rinse1900 mL in 1 BOTTLE, PUMPLIQUID19008
64778-0446-3Denti-Care Denti-RinseNeutral Sodium Fluoride Oral Rinse12 in 1 CASELIQUID128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64778-0446DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AMD MEDICOM]7Current NDC, Legacy NDC, 2 package rows20210128_1da64824-9389-4109-bea9-b91600caf023.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sodium fluorideACTIVE INGREDIENT8ZYQ1474W7DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE (SODIUM FLUORIDE) LIQUID [AR MEDICOM INC]1
fluoride ionACTIVE MOIETYQ80VPU408ODENTI-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.

Matched openFDA labels page 48 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOOBY Happy Hippo CakeSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCda461cb0-430d-458a-98c0-f713e8d51ddd2023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Turtle MelonSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLC1dd2d298-ea9a-44d3-85c2-0c000834e7942023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
Natrum FluoratumNATRUM FLUORATUMHahnemann Laboratories, INC.e54bdb28-890b-4869-e053-2995a90a8efd2022-08-02Exact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental5fa57e34-5827-4d37-a5dc-965750e5be502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental6a0f889d-5f27-496f-b830-d778ee867ade2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental8f5d420b-3348-4002-9a09-b05e8cbb35c92022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentalc93f67f5-9833-4a7a-a67a-49a51843e68d2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentald5658bf8-3a13-4d8b-b727-5f15759195712022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inca7259222-4ee1-42b2-8beb-3f29a5eb29092022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inc0fb4d584-36e8-4db7-b72e-04608580dacd2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc2531ad94-b229-4212-a7a3-f793567a06b62022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc804e7850-1952-4e86-804e-d800ee6e7b502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc87b3b8b8-780f-492d-bd75-b005edd55baa2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc79fa0a42-bb69-49db-9997-1679a75bac262022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Incd7422939-c28e-4bda-b679-81abcc8c36e22022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc192c4e46-0bfd-4f48-901c-ce4f09f91e3e2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc5ef9652f-4d99-493d-97ee-9807c6f391822022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc8d1997c0-4f61-46b5-954e-620d521d3fba2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc9cbfd85a-a930-4a4b-a362-b142f6312c592022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc26b1f8ab-3540-4c3f-95ab-e9cb1c5cee972022-01-25WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.