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 29 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Sensitive Whitening TPSODIUM FLUORIDETargetab9a129e-337b-31fe-e053-2995a90ac6912025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Signature Care Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83225fe5-0490-eb4b-e053-2a91aa0a68792025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Rite Aid Extra WhiteningFLUORIDERite Aidefe2c6c1-b8c6-4a52-b3c6-c9bfca4505702025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Sound Body Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEBig Lots Stores, Inc.81a0a712-76e1-133f-e053-2a91aa0a001a2025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Top Care Enamel GuardFLUORIDETOPCO Assoc. LLC8c5f7b56-6c53-47cf-b39a-cfa2e7fad40c2025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Care One Maximum StrengthFLUORIDEAmerican Sales24715cc7-cf02-4ea0-a491-2a111ad3660e2025-11-14WarningsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride ChewableSODIUM FLUORIDEBryant Ranch Prepack264d02da-d8fb-4a71-95e6-bab74fd82a152025-11-13Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride ChewableSODIUM FLUORIDEBryant Ranch Prepack11bb5a3d-abc5-4460-99d8-09d8494914462025-11-13Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride ChewableSODIUM FLUORIDEBryant Ranch Prepackba5f6fbd-0132-4dac-b047-32f187a2503e2025-11-13Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
HEB HEBuddyFLUORIDEHEBa6af1baf-17bf-428c-8744-1490359b0cfb2025-11-13WarningsExact identifier
unii: 8ZYQ1474W7
Kroger Enamel Protection Sensitive Gentle WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEKroger Company82b9a954-2a53-ac56-e053-2991aa0abd0e2025-11-13WarningsExact identifier
unii: 8ZYQ1474W7
Sensitive Extra WhiteningSODIUM FLUORIDEPublix Super Market16eddce3-03e4-4c0e-e063-6294a90ae94d2025-11-13WarningsExact identifier
unii: 8ZYQ1474W7
Pronamel Repair WhiteningPRONAMEL REPAIR WHITENINGPublix Super Market Inc16ee2625-3641-205d-e063-6394a90a742f2025-11-13WarningsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride ChewableSODIUM FLUORIDEBryant Ranch Prepackce6968ce-30ee-48d5-8648-52b4efd38fe82025-11-13Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Allday 5000 Sensitive1.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Care401f5e96-095b-c001-e063-6394a90ab55e2025-11-12WarningsExact identifier
unii: 8ZYQ1474W7
Dr Tichenors With Extra Whitening and Tartar ControlSODIUM FLUORIDEDr. G. H. Tichenor's Antiseptic Companybce596e8-07eb-4e56-9007-9d283e14372d2025-11-12WarningsExact identifier
unii: 8ZYQ1474W7
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC8d187823-7e56-441b-8bca-8f03e7bb07c72025-11-12WarningsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride ChewableSODIUM FLUORIDEBryant Ranch Prepackbe789a6f-b4b4-4088-aaeb-bcbc6ae1e33b2025-11-12Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Super Chocolate PrescriptionANTICAVITY TOOTHPASTESuperMouth, LLC.bbaccbe4-82ac-4c51-8fc4-a96bf86dfef22025-11-12WarningsExact identifier
unii: 8ZYQ1474W7
Super Mint PrescriptionANTICAVITY TOOTHPASTESuperMouth, LLC.6773eb58-93b0-4e86-b780-7dde378c0bc32025-11-12WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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