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 47 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
unii: 8ZYQ1474W7
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
unii: 8ZYQ1474W7
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
unii: 8ZYQ1474W7
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
unii: 8ZYQ1474W7
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
unii: 8ZYQ1474W7
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
unii: 8ZYQ1474W7
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
unii: 8ZYQ1474W7
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
unii: 8ZYQ1474W7
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
unii: 8ZYQ1474W7
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
unii: 8ZYQ1474W7
Acclean Foam Fluoride 60 Second ApplicationSODIUM FLUORIDEHenry Scheinc10af938-0537-2425-e053-2a95a90ad6082023-10-03WarningsExact identifier
unii: 8ZYQ1474W7
FLUORIDEXSODIUM FLUORIDEDENT-MAT HOLDINGS, LLC.6050ef4d-50e8-55d7-e053-2991aa0ad0762023-08-03Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Denta 5000 PlusSODIUM FLUORIDERising Pharma Holdings, Inc.7142eb93-54ff-4ba1-af43-3fa3dc1fad012023-07-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Tap Water DetoxACETONE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARSENICUM METALLICUM, BARYTA MURIATICA, CADMIUM METALLICUM, CARBOLICUM ACIDUM, CHLORINUM, CHROMIUM (METALLICUM), CUPRUM METALLICUM, FERRUM METALLICUM, GERMANIUM METALLICUM, NATRUM FLUORATUM, PLUMBUM METALLICUM, RADIUM BROMATUM, VANADIUM METALLICUM, GLYPHOSATE HERBICIDENutritional Specialties, Inc.37a48fea-a8df-4d27-b0c7-e5704c25e72f2023-07-11WarningsExact identifier
unii: 8ZYQ1474W7
DentaGelSODIUM FLUORIDERising Pharma Holdings, Inc.cda9e1f6-275d-43ba-9e30-f34094e80d952023-05-09Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent Fresh MintSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2ecc57ec-cd25-4911-9247-6375569b8abe2023-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
DARBY APF STRAWBERRYSODIUM FLUORIDEDarby Dental Supply, LLC222b29dc-7ad0-4872-9922-970efad8b7a72023-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Growlin GrrrapeSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCfcebb175-d412-4452-9c7c-a38571006bfc2023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Gator GumSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCc257d280-8cf3-43e4-b7b7-0a46f493d5b62023-01-03WarningsExact identifier
unii: 8ZYQ1474W7
ZOOBY Spearmint SafariSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCbd49f704-4fc4-42a3-aa87-2b41d15d86bb2023-01-03WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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