Over-the-counter medication · Vitamin D3 Supplement

cholecalciferol

Also sold as Vitamin D3. PNV-DHA is used to help people who don't get enough nutrients from their diet.

Data updated 2026-05-15

4
Recall records

cholecalciferol (Vitamin D3) is an over-the-counter Vitamin D3 Supplement. PNV-DHA is used to help people who don't get enough nutrients from their diet.

PNV-DHA is a multivitamin with minerals and essential fatty acids. It helps if you have nutritional deficiencies or need more nutrients.

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What it does

PNV-DHA is used to help people who don't get enough nutrients from their diet.

Common side effects

No common side effects listed.

Key warnings

Accidental overdose of iron can cause fatal poisoning in children under 6.

The sections below are summarized in plain English from cholecalciferol's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

This medicine gives you important vitamins, minerals, and fatty acids. These nutrients help your body work properly. It fills in the gaps if you are not getting enough from food.

Serious Warnings

Accidental overdose of iron can cause fatal poisoning in children under 6. Keep this medicine away from children. If a child takes too much, call a doctor or poison control center right away.

Common Questions

What is PNV-DHA?
It is a multivitamin with minerals and essential fatty acids.
Who should take PNV-DHA?
People with nutritional deficiencies or those needing extra nutrients.
How often do I take it?
Take one softgel daily.
Can I take it if I am pregnant?
Yes, you can take it before, during, or after pregnancy.
What do I do if I miss a dose?
Take it as soon as you remember, unless it's almost time for your next dose.
Are there any warnings?
Yes, keep it away from children because iron overdose can be dangerous.
What if a child swallows this medicine?
Call a doctor or poison control center immediately.
How should I store this medicine?
Store it at room temperature.
Can this medicine cause an allergic reaction?
Yes, if you are allergic to any of the ingredients, you should not take it.
What does the softgel look like?
Each softgel is blue and has "BP 321" printed on it.
What drug class is cholecalciferol?
cholecalciferol belongs to the Vitamin D3 Supplement drug class. It is available over the counter (OTC). PNV-DHA is used to help people who don't get enough nutrients from their diet.
What pregnancy or breastfeeding source fields are listed for cholecalciferol?
The FDA label for cholecalciferol contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has cholecalciferol been recalled?
There are 4 recalls associated with cholecalciferol products. Lack of Assurance of Sterility. Check the recalls section below for full details and affected products.

Active Recalls

Class II March 7, 2022

Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

Class II November 17, 2016

Lack of Assurance of Sterility

Tri-Coast Pharmacy

Class I November 6, 2015

Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).

Glades Drugs Inc.

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Medication Guides

What the FDA Data Shows for cholecalciferol

The FDA label for cholecalciferol (sold under brand names such as Vitamin D3) classifies it as an over-the-counter product in the Vitamin D3 Supplement class. PNV-DHA is used to help people who don't get enough nutrients from their diet. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 4 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: January 15, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page