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#

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 49 of 52 · 1,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLCacb56376-a6da-45e0-9896-a890137d6c2d2022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLCb4b69649-62f9-47bf-9d93-29d06c6fb6522022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLC90a5acb3-f8cb-1e82-e053-2995a90a4e972022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLC90a59a06-d020-1bab-e053-2995a90a57aa2022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLC90a3cb10-c205-278d-e053-2a95a90a848e2022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLC90a5f14b-97e8-7757-e053-2a95a90a3d972022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
60 Second Fluoride GelSODIUM FLUORIDEDarby Dental Supply, LLC90a2e268-bee8-498d-e053-2995a90ad52b2022-01-24WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.898c0b7f-7ebb-4dba-9ebf-9d1e4805a8c62022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.ec50b003-cf61-4f66-bb62-f779e48363c22022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.f05390e2-9a0a-46fc-9da4-ad2651487b0a2022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.57d70fbe-a0cc-4aaa-b2c7-b9843455d1d92022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.1c5e2cf3-99ef-4737-941e-bc7fb90259e42022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.9cc82e34-9b2d-4815-b9ff-99d2292faff22022-01-21WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.26f3c9a5-7181-4d82-8fa2-21cebd0906202022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.2bf99955-b32e-498e-87dd-a91c8af259482022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.a857af18-8eb8-47dc-bb26-73a321ed643c2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.0dedcb47-7851-4fde-8a46-7d1155839a572022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc2ba4a209-c56f-4cbe-8727-d428d2090b082022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc129ecbf8-17c8-4259-a4ca-7c0a09298bb02022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc852de04d-f608-4f7f-b76b-25a29967c0902022-01-20WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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