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 6 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity mouth rinse Low-foaming Spearmint718 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited5356d0a8-2db4-ce7f-e063-6394a90aa6d22026-06-26WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Companyf87d6f04-507a-47ae-8a66-204cf59261c02026-06-26WarningsExact identifier
unii: 8ZYQ1474W7
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513ba92-cadc-2cf3-e063-6294a90ac3e52026-06-25WarningsExact identifier
unii: 8ZYQ1474W7
Crest Plus Active Fresh Scope plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5513e40f-b8e8-2d9a-e063-6394a90ab1702026-06-25WarningsExact identifier
unii: 8ZYQ1474W7
Crest 3D White Stain Eraser Mint SplashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6c690e-a1bb-4606-e063-6394a90ac4b62026-06-25Exact identifier
unii: 8ZYQ1474W7
Crest 3D White Stain Eraser Daily Stain Prevention Polishing MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bbc3d-a1f9-b278-e063-6294a90a62f72026-06-25Exact identifier
unii: 8ZYQ1474W7
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f1bd56c-dac8-eb87-e063-6294a90a3cc12026-06-25Exact identifier
unii: 8ZYQ1474W7
Crest 3D White Stain Eraser Daily Stain Prevention Icy Clean MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0b1d46-d52c-f409-e063-6394a90a55742026-06-25Exact identifier
unii: 8ZYQ1474W7
Crest Plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5514e09e-0a7d-93e6-e063-6294a90ae3f02026-06-25WarningsExact identifier
unii: 8ZYQ1474W7
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Company890c4c29-bba8-4775-a053-10c6292df9302026-06-24WarningsExact identifier
unii: 8ZYQ1474W7
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55004d9d-eda7-a285-e063-6294a90ad4ca2026-06-24WarningsExact identifier
unii: 8ZYQ1474W7
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.5500686c-d417-c50a-e063-6294a90ac7fa2026-06-24WarningsExact identifier
unii: 8ZYQ1474W7
Crest Premium Plus Scope Active Foam plus Whitening Dualblast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5500f9ab-b0c4-51d6-e063-6394a90acd382026-06-24WarningsExact identifier
unii: 8ZYQ1474W7
Crest Premium Plus Deep Clean Active Foam plus Whitening Foaming MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company5504ec96-aae1-f5f9-e063-6294a90ad8bb2026-06-24WarningsExact identifier
unii: 8ZYQ1474W7
COLGATE SPARKLING WHITE CINNAMINTSODIUM FLUORIDEColgate-Palmolive Companyf2ff18d2-4ef0-454e-a6f1-6f3bf361c7d12026-06-24WarningsExact identifier
unii: 8ZYQ1474W7
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 Plus FruitasticSODIUM FLUORIDEColgate Oral Pharmaceuticals Inc.5ef93306-59dd-447b-a2ec-dd865e52c76b2026-06-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent 5000 Booster Plus SpearmintSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.4ef2b7ed-41c3-41cb-8ee0-1930ab8fb1982026-06-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PreviDent Alcohol FreeSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.28e4f7cd-9fd8-4c7a-9e4b-d747fefc76c02026-06-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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