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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1C6V77QF41Internal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1596005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
54eeeeda-9314-4b7c-9efc-0bedfffb91b6Available on FDA.report

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

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
FlorivaCHOLECALCIFEROL AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.54eeeeda-9314-4b7c-9efc-0bedfffb91b62024-02-01WarningsExact identifier
ndc (product): 52796-172

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