FDA.reportPublic FDA data

Floriva ™ 1 mg TABLETS

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 20:59:17

Label at a glance#

ProductFloriva
Active ingredientVITAMIN A ACETATE, BETA CAROTENE, Ascorbic acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, SODIUM FLUORIDE
Label structure10 sections

Dosage and administration

USE AS DIRECTED BY YOUR PHYSICIAN.

Storage and handling

You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25º Celsius (68-77º Fahrenheit) away from heat and sunlight. Store in original container. The numeric identifier 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. Th...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Supplement Facts
Serving Size: 1 tablet
Servings Per Container: 90
Amount per tablet% Daily Value*
Vitamin A (50% beta carotene/50% acetate)2000 IU40%
Vitamin C (ascorbic acid)75 mg125%
Vitamin D3 (cholecalciferol)600 IU150%
Vitamin E (dl alpha tocopherol acetate)20 IU67%
Vitamin B1 (thiamine)1.3 mg87%
Vitamin B2 (riboflavin)1.5 mg88%
Niacin (nicotinamide)15 mg75%
Vitamin B6 (pyridoxine)1.8 mg90%
Folate (as 300 mcg Quatrefolic R ((6S-5-methyltetrahydrofolic acid, glucosamine salt†, molar equivalent to 162 mcg of folic acid) and 100 mcg of folic acid) Quatrefolic CAS #: 1181972-37-1262 mcg 66%
Vitamin B12 (cyanocobalamin)6 mcg100%
Biotin40 mcg13%
Zinc (zinc gluconate)5 mg33%
Copper (cupric oxide)1 mg50%
Fluoride (sodium fluoride)1 mg†

* Percent Daily Value (%DV) for Adults and Children 4 or more years of age based on a 2000 calorie diet.

† Daily Value not established.

Other Ingredients

SPL UNCLASSIFIED SECTION

Natural berry flavor, bitterness masking agent, MCC, sucralose, talc, magnesium stearate, xylitol (DC and regular grade).

Description

DESCRIPTION SECTION

Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "177" on one side and scored on the other.

Directions

DOSAGE & ADMINISTRATION SECTION

USE AS DIRECTED BY YOUR PHYSICIAN.

Tamper Evident Feature

SPL UNCLASSIFIED SECTION

Do not use if inner-seal beneath cap is missing or broken.

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. TABLET SHOULD BE CHEWED. THIS TABLET, AS WITH ALL TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE OF 4 DUE TO RISK OF CHOKING.

CAUTION

PRECAUTIONS 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). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25º Celsius (68-77º Fahrenheit) away from heat and sunlight. Store in original container.

The numeric identifier 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.

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

SPL UNCLASSIFIED SECTION

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

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

LOT/EXP

Quatrefolic Trademark and Patent property of Gnosis SpA.

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 mg*
FLUORIDE
TABLETS

BonGeo™
PHARMACEUTICALS

52796-177-90

Floriva™
1 mg TABLETS

Chewable Fluoride Multivitamin

Quatrefolic®

Patent Ref.: U.S. Patent No. 7,947,662;
Other patents pending

Natural Berry Flavor

Rx Dietary Supplement

90 Chewable Tablets

*contains 1 mg fluoride
from 2.2 mg sodium fluoride

• SUGAR FREE AND GLUTEN FREE • NO ARTIFICIAL COLORS OR DYES •

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52796-177-902024-02-01C16284748780-11030e365-2476-111a-e063-dadaa90a10e2Floriva ™ 1 mg TABLETS
52796-177-902024-01-30C16284748780-11030e365-2476-111a-e063-dadaa90a10e2Floriva ™ 1 mg TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52796-177-90Floriva90 in 1 BOTTLETABLET, CHEWABLE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52796-177FLORIVA (VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDE) TABLET, CHEWABLE [BONGEO PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240202_768502e2-541f-4de8-ac68-3ab47c1f436d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52796-177-90EA - Each52796-1777a19baf6-043b-42e8-b077-769fd8c5f7f212014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROLACTIVE INGREDIENTH4N855PNZ11
.BETA.-CAROTENEACTIVE INGREDIENT01YAE03M7J1
Ascorbic acidACTIVE INGREDIENTPQ6CK8PD0R1
BIOTINACTIVE INGREDIENT6SO6U10H041
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
CUPRIC OXIDEACTIVE INGREDIENTV1XJQ704R41
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
LEVOMEFOLATE GLUCOSAMINEACTIVE INGREDIENTQ65PL71Q1A1
NIACINAMIDEACTIVE INGREDIENT25X51I8RD41
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6Z1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
THIAMINEACTIVE INGREDIENTX66NSO3N351
VITAMIN A ACETATEACTIVE INGREDIENT3LE3D9D6OY1
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1Z1
.ALPHA.-TOCOPHEROLACTIVE MOIETYH4N855PNZ11
.BETA.-CAROTENEACTIVE MOIETY01YAE03M7J1
Ascorbic acidACTIVE MOIETYPQ6CK8PD0R1
BIOTINACTIVE MOIETY6SO6U10H041
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
FOLIC ACIDACTIVE MOIETY935E97BOY81
LEVOMEFOLATE GLUCOSAMINEACTIVE MOIETYQ65PL71Q1A1
NIACINAMIDEACTIVE MOIETY25X51I8RD41
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RiboflavinACTIVE MOIETYTLM2976OFR1
Thiamine IonACTIVE MOIETY4ABT0J945J1
VITAMIN AACTIVE MOIETY81G40H8B0T1
ZINC CATIONACTIVE MOIETY13S1S8SF371
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TALCINACTIVE INGREDIENT7SEV7J4R1U1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52796-17752796-177-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN A ACETATE3LE3D9D6OYACTIM
BETA CAROTENE01YAE03M7JACTIB
Ascorbic acidPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1ACTIB
THIAMINEX66NSO3N35ACTIB
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINEKV2JZ1BI6ZACTIB
LEVOMEFOLATE GLUCOSAMINEQ65PL71Q1AACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
BIOTIN6SO6U10H04ACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB
CUPRIC OXIDEV1XJQ704R4ACTIM
SODIUM FLUORIDE8ZYQ1474W7ACTIM
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SUCRALOSE96K6UQ3ZD4IACT
TALC7SEV7J4R1UIACT
MAGNESIUM STEARATE70097M6I30IACT
XYLITOLVCQ006KQ1EIACT

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 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii+route
20 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii+route
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii+route+dosage form
2 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
ndc (package): 52796-177-90
ndc (product): 52796-177
ndc11 (package): 52796017790
spl id: 27070a6d-7f65-4ff8-a733-6c9565653187
spl set id: 768502e2-541f-4de8-ac68-3ab47c1f436d

Reported adverse events (FAERS/openFDA)#

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