Floriva

Product NDC
52796-172
11-digit product format
527960172
Labeler code
52796
Product ID
52796-172_b70f7032-674d-4052-84d9-35ee99f33868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHOLECALCIFEROL and SODIUM FLUORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
BonGeo Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-10-15
Substance
CHOLECALCIFEROL; SODIUM FLUORIDE
Active strength
400; .25 [iU]/mL; mg/mL
Pharmacologic classes
Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Floriva
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLECALCIFEROL400 [iU]/mL
SODIUM FLUORIDE.25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1C6V77QF41, 8ZYQ1474W7
Rxcui1596005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52796-172-502024-02-01C16284748780-11030e364-f96d-111a-e063-dadaa90a10e2Floriva ™ 0.25 mg DROPS
52796-172-502024-01-30C16284748780-11030e364-f96d-111a-e063-dadaa90a10e2Floriva ™ 0.25 mg DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52796-172-50Floriva1 in 1 BOXLIQUID14
52796-172-50Floriva50 mL in 1 BOTTLE, DROPPERLIQUID504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52796-172-50ML - Milliliter52796-172b4dd960c-e721-414a-a6fe-3102f2046a6612014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41FLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7FLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41FLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OFLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4FLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52796-172FLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240202_54eeeeda-9314-4b7c-9efc-0bedfffb91b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596005vitamin D3 10 MCG (400 UNT) / sodium fluoride 0.25 MG in 1 mL Oral SolutionPSN54eeeeda-9314-4b7c-9efc-0bedfffb91b64
1596005cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML Oral SolutionSCD54eeeeda-9314-4b7c-9efc-0bedfffb91b64
1596005cholecalciferol 400 UNT/ML / sodium fluoride 0.55 MG/ML Oral SolutionSY54eeeeda-9314-4b7c-9efc-0bedfffb91b64
1596005vitamin D3 0.01 MG/ML (400 UNT/ML) / sodium fluoride 0.55 MG/ML (fluoride ion 0.25 MG/ML) Oral SolutionSY54eeeeda-9314-4b7c-9efc-0bedfffb91b64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52796-172-50527960172501 BOTTLE, DROPPER in 1 BOX (52796-172-50) / 50 mL in 1 BOTTLE, DROPPER2014-10-150000-00-00NoNoCurrent