Iris versicolor

IRIS VERSICOLOR ROOT ORAL HUMAN OTC DRUG

Iris versicolor is an FDA drug label for the active ingredient IRIS VERSICOLOR ROOT manufactured by Boiron administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260507.

Generic name
IRIS VERSICOLOR ROOT
Manufacturer
Boiron
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0220-2693
Application
N/A
Label effective
20260507

About this product

Iris versicolor is an FDA-registered drug product whose active ingredient is IRIS VERSICOLOR ROOT. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-2693, label effective 20260507. It is one of 6 FDA drug label records sharing the active ingredient IRIS VERSICOLOR ROOT. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing IRIS VERSICOLOR ROOT are most often described in connection with: temporarily relieves, minor headache, accompanied sour, stomach heartburn. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient** (in each pellet) Iris versicolor 6C HPUS (0.44 mg) The letters “HPUS” indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Indications & Usage

Uses* temporarily relieves minor headache pain which may be accompanied by: ▪ sour stomach ▪ heartburn

Dosage & Administration

Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor. Children under 12 years of age: Ask a doctor.

How products containing IRIS VERSICOLOR ROOT compare

FDA lists 6 drug label records with IRIS VERSICOLOR ROOT as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Boiron 6
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Recall and safety notices

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0803-2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA Boiron Inc. Class III Terminated 20180523
D-0888-2021 ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%, Manufactured for Optimal Health Dimensions, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 25411, Washington Homeopathic Products, Inc. Class II Terminated 20211006

Frequently asked questions

What is Iris versicolor used for?
Uses* temporarily relieves minor headache pain which may be accompanied by: ▪ sour stomach ▪ heartburn

Who makes Iris versicolor?
Boiron is the labeler of record for Iris versicolor. 6 FDA label records share the active ingredient IRIS VERSICOLOR ROOT, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Iris versicolor come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Iris versicolor prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing IRIS VERSICOLOR ROOT?
Yes. 6 FDA drug label records list IRIS VERSICOLOR ROOT as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Iris versicolor been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.