FDA.reportPublic FDA data

Denti-Care Denti-Rinse

Product NDC
64778-0446
11-digit product format
647780446
Labeler code
64778
Product ID
64778-0446_4c4b0fd6-ca08-179a-e063-6394a90a6628
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
LIQUID
Route
DENTAL
Labeler
AMD Medicom
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2001-03-01
Marketing end
2027-05-31
Substance
SODIUM FLUORIDE
Active strength
.02 g/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Denti-Care Denti-Rinse
Brand name suffix
Neutral Sodium Fluoride Oral Rinse

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.02 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251960Internal RxNorm lookup
991007Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1da64824-9389-4109-bea9-b91600caf023Available on FDA.report

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 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

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral RinseSODIUM FLUORIDEAMD Medicom1da64824-9389-4109-bea9-b91600caf0232026-03-05WarningsExact identifier
ndc (product): 64778-0446

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991007Denti-Care DENTI-RINSE 2 % Oral RinsePSN1da64824-9389-4109-bea9-b91600caf0238
251960sodium fluoride 2 % Oral RinsePSN1da64824-9389-4109-bea9-b91600caf0238
991007sodium fluoride 20 MG/ML Mouthwash [DentiCare Neutral]SBD1da64824-9389-4109-bea9-b91600caf0238
251960sodium fluoride 20 MG/ML MouthwashSCD1da64824-9389-4109-bea9-b91600caf0238
991007DentiCare Neutral 2 % MouthwashSY1da64824-9389-4109-bea9-b91600caf0238
991007DentiCare Neutral 20 MG/ML MouthwashSY1da64824-9389-4109-bea9-b91600caf0238
251960sodium fluoride 2 % Oral RinseSY1da64824-9389-4109-bea9-b91600caf0238

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64778-0446-1647780446011900 mL in 1 BOTTLE, PUMP1900 mlHistorical
64778-0446-36477804460312 BOTTLE, PUMP in 1 CASE (64778-0446-3) / 1900 mL in 1 BOTTLE, PUMP (64778-0446-1) 2017-12-012027-05-31NoNoCurrent