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 33 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
FluoriMax 5000 Sensitive1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTEElevate Oral Cared9f232c0-d154-536b-e053-2995a90af37d2025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
FluoriMax 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Cared9e462d9-f0fd-4168-e053-2995a90a95b22025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careac24342d-382e-6fc2-e053-2a95a90acd692025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careadf0c686-e6a1-03f5-e053-2a95a90ac7552025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Just Right 50001.1% SODIUM FLUORIDE TOOTHPASTEElevate Oral Careadf22ce4-b567-5274-e053-2a95a90a85362025-09-19WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.f70d378b-d4d6-454c-90a9-794459960c8c2025-09-17WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies Chocolate Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.26b9b2dd-7cb2-47c3-8bbb-94a48f02dd212025-09-16WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.3436532d-e078-4dbb-a823-b4542e9615342025-09-16WarningsExact identifier
unii: 8ZYQ1474W7
Cavity Protection Fresh Mint Anticavity MouthwashSODIUM FLUORIDEOxyfresh Worldwide Inc3efc66b2-fcf9-4d26-9cdd-1af8225312b42025-09-10WarningsExact identifier
unii: 8ZYQ1474W7
CLOSE UP Freshening with MouthwashSODIUM FLUORIDEChurch & Dwight Co., Inc.e660b0d7-4cc5-4028-bdf5-016b858997282025-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Essentials Healthy Teeth and GumsSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.9652c004-6b47-840f-e053-2995a90a6e982025-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Complete Care Whole Mouth ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.d00f9d16-de0e-4ffc-e053-2a95a90a20692025-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies Vanilla Ice Cream FLAVORED Anticavity FluorideSODIUM FLUORIDEAshtel Studios, Inc.e911effb-d59f-4054-9501-803b64369ab42025-09-05WarningsExact identifier
unii: 8ZYQ1474W7
PCXX ANTICARIES NO FLAVOR NE GSODIUM FLUORIDERoss Healthcare Inc.8296923b-a0a9-3bc8-e053-2991aa0a015a2025-09-04Exact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RNS STRAWBERRYFLUORIDE TREATMENTRoss Healthcare Inc.14234397-211b-d30a-e063-6394a90a9db62025-09-04WarningsExact identifier
rxcui: 251960
unii: 8ZYQ1474W7
PCXX COOL PEPPERMINT APF GSODIUM FLUORIDERoss Healthcare Inc.8115e332-3552-0a09-e053-2a91aa0a92212025-09-04Exact identifier
unii: 8ZYQ1474W7
The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD3de10638-1a39-b747-e063-6294a90a4ca52025-09-03WarningsExact identifier
unii: 8ZYQ1474W7
Multivitamin with FluorideSODIUM FLUORIDEWINDER LABORATORIES, LLCa10ff759-eba7-414b-bb98-f17fbb6e6b572025-08-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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