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 11 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.5f87abb7-0e9d-6369-e053-2a91aa0a24112026-03-31WarningsExact identifier
unii: 8ZYQ1474W7
PRO-SYSPOTASSIUM NITRATE, SODIUM FLUORIDEBenco Dental4c9c144a-f28e-756d-e063-6394a90a59712026-03-31WarningsExact identifier
unii: 8ZYQ1474W7
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack696cb342-fc5c-47cf-bbc8-5ecc706074c02026-03-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0800f4ef-1d98-4c0f-a016-501791973f662026-03-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack0f11c8c7-c73e-4610-83ed-e697539ac1802026-03-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DBryant Ranch Prepack15c78a03-17d7-43af-978f-1a64bd2240fe2026-03-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Kroger Extra WhiteningFLUORIDEKrogere704c690-1383-4cd6-be85-28bdd9ff936b2026-03-24WarningsExact identifier
unii: 8ZYQ1474W7
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
unii: 8ZYQ1474W7
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackf28c8928-81c3-458a-9ce2-2aaca3b7527d2026-03-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackef79cadb-c553-4af1-9a53-6ea1ab26b4bb2026-03-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Tri-Vite Drops with FluorideASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN DBryant Ranch Prepackfe9da1e9-9b36-4702-bec2-13187f0f65482026-03-18Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
DentoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, LYMPH NODE(SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA FLUORICA, NATRUM FLUORATUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMBioActive Nutritional, Inc.dbe965b3-e81e-4328-bc41-43e875e12a052026-03-18WarningsExact identifier
unii: 8ZYQ1474W7
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack6607fcec-2da9-47df-ad92-1d545f7bf5352026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack3c3acbdd-0bcb-4798-b6c5-242bdcd352b12026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepack5568579f-3445-4f04-a936-33c78b33392c2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Multivitamin with Fluoride.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CYANOCOBALAMIN, FOLIC ACID, NIACIN, PYRIDOXINE, RIBOFLAVIN, SODIUM FLUORIDE, THIAMINE MONONITRATE, VITAMIN A AND VITAMIN DBryant Ranch Prepackb7f1c321-5a00-4b89-8cb4-fa250e74d9db2026-03-17Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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