FDA.reportPublic FDA data

OneVite Pediatric D-VITE

Manufacturer
Akron Pharma
Effective date
2026-04-10
Label type
DIETARY SUPPLEMENT
Version
5
Source
full-release
Hydrated at
2026-06-01 02:52:47

Label at a glance#

ProductD-Vite Pediatric Oral Liquid
Active ingredientCHOLECALCIFEROL
Label structure7 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

 Supplement Facts

 Serving Size:  1 mL Daily

Serving per Container:50

 Amount Per mL (dropperful)                                                          % Daily Value                                                                
                                                             Infants through 12 months of age      Children 1 through 4 years of age

400 IU/mL

(CHOLECALCIFEROL)                                                                        100%                                                          150%  

HEALTH CLAIM SECTION

D-VITE Drops provides essential vitamin that helps your baby's body absorb calcium for strong bones and teeth.*

D-VITE Drops complements your breast milk to help provide optimal nutrition for your baby. *

* This statment has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure or prevent any disease.

SAFE HANDLING WARNING SECTION

Storage:  Store at room temperature 15º -30ºC(59º -86ºF).  Protect from freezing.  After opening, store away from direct light.  Refrigerator is not required.

WARNINGS SECTION

WARNING:  As with medicine, Keep out of reach of children.

PRECAUTIONS SECTION

SHAKE WELL BEFORE USE.

DOSAGE & ADMINISTRATION SECTION

Directions for use:

Administer this supplement using only the device provided  Shake bottle well and fill dropper to 1.0 ml. line.  Dosage not to exceed 1.0 ml. per day unless doctor recommends another dosage.  Dispense directly into mouth or mixed with formula, fruit juice, cereal, or other foods.  Rinse and retain device for further dosing of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

D-Vite Container Label

LabelLabel

D-Vite-Carton-Container Label

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251154vitamin D3 10 MCG (400 UNT) in 1 mL Oral SolutionPSN5
251154cholecalciferol 0.01 MG/ML Oral SolutionSCD5
251154cholecalciferol 400 UNT/ML Oral SolutionSY5
251154vitamin D3 10 MCG (400 UNT) per ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371399740151GTIN-13: 0371399740151
EAN-13: 0371399740151
GTIN-12: 371399740151
UPC-A: 371399740151
GTIN storage (14 digits): 00371399740151		D-VITE-lbl.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-7401-5D-Vite Pediatric Oral Liquid50 mL in 1 BOTTLE, DROPPERSOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-7401-5ML - Milliliter71399-74015dc29ef2-e585-47b0-a41e-c857c073b8d512021-06-02

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-740171399-7401-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHOLECALCIFEROL1C6V77QF41ACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
CARAMELT9D99G2B1RIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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