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 14 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral AntivavitySODIUM FLUORIDEMeijer, Inc.af34f83f-1328-4897-9d04-72ca5a4101bf2026-02-19Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEMeijer, Inc.acff939e-e98c-4d89-a0c4-0254dc74e6722026-02-19Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity fluoride rinseSODIUM FLUORIDEMeijer, Inc.0bb9fb5f-1893-4187-b60b-05319a8fac6a2026-02-19Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Listerine Total Care Intense Anticavity Fluoride MouthwashSODIUM FLUORIDEKenvue Brands LLC4b0404af-309f-7c31-e063-6294a90a5aa12026-02-18WarningsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDETarget Corporationabfc1973-60ab-44e5-8147-33739d8bd7a32026-02-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDETarget Corporation3e4119b2-9506-4305-8cff-163f700265d02026-02-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Toms of Maine Whiten Plus Deep Clean PeppermintSODIUM FLUORIDETom's of Maine4c535776-3f80-4eeb-bb63-2d734c3c3a6b2026-02-18WarningsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
unii: 8ZYQ1474W7
AQUAFRESH CAVITY PROTECTIONSODIUM FLUORIDEHaleon US Holdings LLC5484999c-8e6f-430d-99a5-6893a24894672026-02-16WarningsExact identifier
unii: 8ZYQ1474W7
AQUAFRESH EXTREME CLEAN WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
unii: 8ZYQ1474W7
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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