Cobalefol

Manufacturer
V2 Pharma LLC
Effective date
2025-05-16
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:33:30

Label at a glance#

ProductCobalefol
Active ingredientASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN 5'-PHOSPHATE, NIACINAMIDE, PYRIDOXINE HCL, FOLIC ACID, METHYLCOBALAMIN
Label structure7 sections

Storage and handling

Store at room temperature. Avoid excessive heat, light, and moisture.  These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Cobalefol vitamin capsules are available in 30 count bottles. 72835-550-01 Manufactured for: V2 Pharma, LLC 103 W Main Street Hudson, MI 49247

Label contents#

Full prescribing information#

Supplement Facts

STATEMENT OF IDENTITY SECTION

Cobalefol Capsules - Vitamins dispensed by prescription

Supplement Facts

Serving Size: 1 Capsule

Servings Per Bottle: 30

 Ingredients Amount Per Serving%DV
 Vitamin C (as Ascorbic Acid) 90 mg 100%
 Vitamin D3 (as Cholecalciferol) 20 mcg 100%
 Vitamin E (as d-Alpha Tocopheryl Succinate) 10.05 mg 67%
 Thiamine (as Thiamine Mononitrate) 1.4 mg 116%
 Riboflavin (as Riboflavin 5 Phosphate) 1.6 mg 123%
 Niacin (as Niacinamide) 16.3 mg 101%
 Vitamin B-6 (as Pyridoxine HCl) 2.5 mg 147%
 Folate (from 1000 mcg Folic Acid) 1700 mcg DFE 425%
 Vitamin B-12 (as Methylcobalamin) 10 mcg 416%

Other ingredients: Microcrystalline Cellulose (USP), Vegetable Capsule (cellulose, purified water)

Description:

STATEMENT OF IDENTITY SECTION

Cobalefol is an orally administered vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is needed. Cobalefol provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, and thiamine mononitrate to supplement the diet.

Contraindications

PRECAUTIONS SECTION

Cobalefol is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.

Precaution

SPL UNCLASSIFIED SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Cobalefol should only be used under the direction and supervision of a licensed medical practitioner.

WARNINGS

WARNINGS SECTION

KEEP COBALEFOL OUT OF THE REACH OF CHILDREN.
In case of accidental overdose, call a licensed medical practitioner or poison control center immediately.
For use under the supervision of a licensed medical practitioner.

Consult your physician prior to using Cobalefol if you are pregnant, nursing, taking medication, or have a medical condition. 

Doseage and Administration

DOSAGE & ADMINISTRATION SECTION

Suggested use is 1 capsule taken orally once daily or as prescribed by a licensed medical practitioner. 

Storage and Handling

SAFE HANDLING WARNING SECTION

Store at room temperature. Avoid excessive heat, light, and moisture. 

Statements

SPL UNCLASSIFIED SECTION

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

How Supplied

SPL UNCLASSIFIED SECTION

Cobalefol vitamin capsules are available in 30 count bottles. 72835-550-01

Manufactured for:
V2 Pharma, LLC
103 W Main Street
Hudson, MI 49247

Cobalefol Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cobalefol LabelCobalefol Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
RIBOFLAVIN 5'-PHOSPHATE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230420

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e6383094-adb3-4e58-af3e-6e58e32b9740Product name220210330
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72835-550-01Cobalefol30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72835-550COBALEFOL (VITAMIN) CAPSULE [V2 PHARMA LLC]1Current NDC, 1 package rows20250520_7d409065-112d-4bc7-bae6-d558aeb7c0e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72835-550-01EA - Each72835-550478303fd-989d-4341-9d52-8dbcc716b17312025-06-13

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72835-55072835-550-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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
CobalefolVITAMINV2 Pharma LLC7d409065-112d-4bc7-bae6-d558aeb7c0e42025-05-16WarningsExact identifier
ndc (package): 72835-550-01
ndc (product): 72835-550
ndc11 (package): 72835055001
spl id: 9a9099c2-4b67-4e39-9bd3-924ae7a4e667
spl set id: 7d409065-112d-4bc7-bae6-d558aeb7c0e4

Reported adverse events (FAERS/openFDA)#

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