Pro Care Flouride

Product NDC
78989-001
11-digit product format
789890001
Labeler code
78989
Product ID
78989-001_ac8aa365-f122-366d-e053-2a95a90a0379
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL
Route
DENTAL
Labeler
DILIGO HOLDINGS JOINT STOCK COMPANY
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-05
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78989-001-012022-01-28C16284748780-1d6a99b39-931a-a426-e053-dadaa90af4c2Pro Care Flouride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78989-001-01Pro Care Flouride1 in 1 BOXGEL11
78989-001-01Pro Care Flouride185 g in 1 TUBEGEL1851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78989-001PRO CARE FLOURIDE (SODIUM FLUORIDE) GEL [DILIGO HOLDINGS JOINT STOCK COMPANY]1Legacy NDC, 2 package rows20200811_ac8a9fd0-5447-2ade-e053-2a95a90a36d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099038sodium fluoride 0.21 % ToothpastePSNac8a9fd0-5447-2ade-e053-2a95a90a36d91
1099038sodium fluoride 0.0021 MG/MG ToothpasteSCDac8a9fd0-5447-2ade-e053-2a95a90a36d91
1099038sodium fluoride 0.21 % ToothpasteSYac8a9fd0-5447-2ade-e053-2a95a90a36d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78989-001-01789890001011 TUBE in 1 BOX (78989-001-01) > 185 g in 1 TUBE1 tube2020-08-050000-00-00NoNoCurrent