Search by Drug Name or NDC
NDC 52796-0172-50 Floriva 400; .25 [iU]/mL; mg/mL Details
Floriva 400; .25 [iU]/mL; mg/mL
Floriva is a ORAL LIQUID in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BonGeo Pharmaceuticals, Inc.. The primary component is CHOLECALCIFEROL; SODIUM FLUORIDE.
MedlinePlus Drug Summary
Cholecalciferol (vitamin D3) is used as a dietary supplement when the amount of vitamin D in the diet is not enough. People most at risk for vitamin D deficiency are older adults, breastfed infants, people with dark skin, obese people, and those with limited sun exposure, or gastrointestinal disease (GI; affecting the stomach or intestines) such as Crohn's disease or celiac disease. Cholecalciferol (vitamin D3) is also used along with calcium to prevent and treat bone diseases such as rickets (softening and weakening of bones in children caused by lack of vitamin D), osteomalacia (softening and weakening of bones in adults caused by lack of vitamin D), and osteoporosis (a condition in which the bones become thin and weak and break easily). Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.
Related Packages: 52796-0172-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cholecalciferol (Vitamin D3)
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 52796-0172-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fluoride
Product Information
| NDC | 52796-0172 |
|---|---|
| Product ID | 52796-172_37f25ef7-c26c-4d93-8924-516fa48f9554 |
| Associated GPIs | 79309902750920 |
| GCN Sequence Number | 073038 |
| GCN Sequence Number Description | sodium fluoride/vitamin D3 DROPS 0.25-400/1 ORAL |
| HIC3 | D2A |
| HIC3 Description | FLUORIDE PREPARATIONS |
| GCN | 37352 |
| HICL Sequence Number | 012456 |
| HICL Sequence Number Description | SODIUM FLUORIDE/CHOLECALCIFEROL (VITAMIN D3) |
| Brand/Generic | Brand |
| Proprietary Name | Floriva |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | CHOLECALCIFEROL and SODIUM FLUORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 400; .25 |
| Active Ingredient Units | [iU]/mL; mg/mL |
| Substance Name | CHOLECALCIFEROL; SODIUM FLUORIDE |
| Labeler Name | BonGeo Pharmaceuticals, Inc. |
| Pharmaceutical Class | Vitamin D [CS], Vitamin D [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 52796-0172-50 (52796017250)
| NDC Package Code | 52796-172-50 |
|---|---|
| Billing NDC | 52796017250 |
| Package | 1 BOTTLE, DROPPER in 1 BOX (52796-172-50) / 50 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2014-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 54eeeeda-9314-4b7c-9efc-0bedfffb91b6 Details
SPL UNCLASSIFIED 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 | † |
Other Ingredients: Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color and propyl paraben.
WARNING
How to Use
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
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.
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
INGREDIENTS AND APPEARANCE
| FLORIVA
cholecalciferol and sodium fluoride liquid |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - BonGeo Pharmaceuticals, Inc. (964822022) |