Floriva ™ 0.25 mg DROPS

Manufacturer: BonGeo Pharmaceuticals, Inc.
Effective date: 2024-02-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 20:59:16

Label at a glance#

ProductFloriva

Active ingredientCHOLECALCIFEROL, SODIUM FLUORIDE

Label structure8 sections

Dosage and administration

Use as directed by a physician

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-844-640-7607

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Supplement Facts
Serving Size: 1 mL
Servings Per Container: 50
	Amount per serving	% Daily Value^*
Vitamin D	400 IU	100%
Fluoride (sodium fluoride)	0.25 mg	^†

* Percent Daily Value (%DV) based on a 2000 calorie diet.

† Daily Value not established.

Other Ingredients: Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color and propyl paraben.

WARNING

WARNINGS SECTION

KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

SHAKE WELL BEFORE USE

Directions

DOSAGE & ADMINISTRATION SECTION

Use as directed by a physician

How to Use

INDICATIONS & USAGE SECTION

Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.

Do not accept if tamper evident box seal is broken or missing.

The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.

Caution

SPL UNCLASSIFIED SECTION

Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives) since these may decrease effectiveness. Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

You may report serious side effects to 1-844-640-7607.

SPL UNCLASSIFIED SECTION

The numeric identifer on this product's labeling is an assigned product code for use with pharmacy-level, health-insurance, and state level reimbursement programs and is not intended to denote registration with the FDA.

Manufactured for:
BonGeo Pharmaceuticals, Inc.
Roseland, NJ 07068

Manufactured by:
Sancilio & Co., Inc.
Riviera Beach, FL 33404

LOT/EXP

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

52796-172-50

BonGeo_™
PHARMACEUTICALS

Floriva_™
0.25 mg DROPS

0.25 mg*
FLUORIDE
DROPS

Fluoride and Vitamin D
Liquid Drops

Fruit Flavor

Rx Dietary
Supplement
1 2/3 FL. OZ (50 mL)

SUGAR, SACCHARIN
AND GLUTEN FREE
NO ARTIFICIAL COLORS OR DYES

*contains 0.25 mg fluoride from 0.55 mg sodium fluoride

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1596005	vitamin D3 10 MCG (400 UNT) / sodium fluoride 0.25 MG in 1 mL Oral Solution	PSN	4
1596005	cholecalciferol 0.01 MG/ML / sodium fluoride 0.55 MG/ML Oral Solution	SCD	4
1596005	cholecalciferol 400 UNT/ML / sodium fluoride 0.55 MG/ML Oral Solution	SY	4
1596005	vitamin D3 0.01 MG/ML (400 UNT/ML) / sodium fluoride 0.55 MG/ML (fluoride ion 0.25 MG/ML) Oral Solution	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHOLECALCIFEROL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52796-172-50	2024-02-01	C162847	48780-1	1030e364-f96d-111a-e063-dadaa90a10e2	Floriva ™ 0.25 mg DROPS
52796-172-50	2024-01-30	C162847	48780-1	1030e364-f96d-111a-e063-dadaa90a10e2	Floriva ™ 0.25 mg DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52796-172-50	Floriva	1 in 1 BOX	LIQUID	1		4
52796-172-50	Floriva	50 mL in 1 BOTTLE, DROPPER	LIQUID	50		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52796-172	FLORIVA (CHOLECALCIFEROL AND SODIUM FLUORIDE) LIQUID [BONGEO PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240202_54eeeeda-9314-4b7c-9efc-0bedfffb91b6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52796-172-50	ML - Milliliter	52796-172	b4dd960c-e721-414a-a6fe-3102f2046a66	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	1
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Floriva
CHOLECALCIFEROL and SODIUM FLUORIDE
CHOLECALCIFEROL
SODIUM FLUORIDE
FLUORIDE ION
GLYCERIN
WATER
POLYSORBATE 80
SODIUM HYDROXIDE
PROPYLENE GLYCOL
SUCRALOSE
METHYLPARABEN
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52796-172	52796-172-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHOLECALCIFEROL	1C6V77QF41	ACTIB
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 98 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	PASTE / ORAL		28 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii+route 52 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, LIQUID FILLED / ORAL		24 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / ORAL	2 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii+route 52 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / ORAL	2 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TROCHE / ORAL		60 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 36 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii+route 36 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii+dosage form 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii+route 52 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii+route 52 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii+route 52 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, FOR SUSPENSION / ORAL		65 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii+route 36 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE, FOR SUSPENSION / ORAL		23 mg	Exact identifier — unii+route 36 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii+route 52 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Floriva	CHOLECALCIFEROL AND SODIUM FLUORIDE	BonGeo Pharmaceuticals, Inc.	54eeeeda-9314-4b7c-9efc-0bedfffb91b6	2024-02-01	Warnings	Exact identifier ndc (package): 52796-172-50 ndc (product): 52796-172 ndc11 (package): 52796017250 spl id: b70f7032-674d-4052-84d9-35ee99f33868 spl set id: 54eeeeda-9314-4b7c-9efc-0bedfffb91b6

Reported adverse events (FAERS/openFDA)#

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