FDA.reportPublic FDA data

Cobalefol

Product NDC
72835-550
11-digit product format
728350550
Labeler code
72835
Product ID
72835-550_9a9099c2-4b67-4e39-9bd3-924ae7a4e667
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VITAMIN
Dosage form
CAPSULE
Route
ORAL
Labeler
V2 Pharma LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-05-16
Substance
.ALPHA.-TOCOPHEROL SUCCINATE, D-; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; METHYLCOBALAMIN; NIACINAMIDE; PYRIDOXINE HCL; RIBOFLAVIN 5'-PHOSPHATE; THIAMINE MONONITRATE
Active strength
10.5; 90; 20; 1700; 10; 16.3; 2.5; 1.6; 1.4 mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing Activity [PE], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], 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
Cobalefol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCORBIC ACID10.5 mg/1
CHOLECALCIFEROL90 mg/1
.ALPHA.-TOCOPHEROL SUCCINATE, D-20 ug/1
THIAMINE MONONITRATE1700 ug/1
RIBOFLAVIN 5'-PHOSPHATE10 ug/1
NIACINAMIDE16.3 mg/1
PYRIDOXINE HCL2.5 mg/1
FOLIC ACID1.6 mg/1
METHYLCOBALAMIN1.4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PQ6CK8PD0RInternal UNII lookup
1C6V77QF41Internal UNII lookup
LU4B53JYVEInternal UNII lookup
8K0I04919XInternal UNII lookup
7N464URE7EInternal UNII lookup
25X51I8RD4Internal UNII lookup
68Y4CF58BVInternal UNII lookup
935E97BOY8Internal UNII lookup
BR1SN1JS2WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7d409065-112d-4bc7-bae6-d558aeb7c0e4Available on FDA.report

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 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

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

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 (product): 72835-550

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72835-550-017283505500130 CAPSULE in 1 BOTTLE (72835-550-01) 30 capsule2025-05-16NoNoCurrent