Hamamelis virginiana
Hamamelis virginiana is an FDA drug label for the active ingredient HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 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 20231113.
- Generic name
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
- Manufacturer
- Boiron
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 0220-2405
- Application
- N/A
- Label effective
- 20231113
About this product
Hamamelis virginiana is an FDA-registered drug product whose active ingredient is HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-2405, label effective 20231113. It is one of 8 FDA drug label records sharing the active ingredient HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK. 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 HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK are most often described in connection with: bursting sensation. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Hemorrhoids With Bursting Sensation*
Dosage & Administration
Adults and children: 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.
How products containing HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK compare
FDA lists 8 drug label records with HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Boiron | 8 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| 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-0880-2021 | Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Only, REMEDY: Amygdalus Persica 10X, Arnica Montana 10X, Bellis Perennis 10X, Chromium Sulphuricum 10X, Citrus Vulgaris 10X, Derris Pinnata 13X, Franciscea Uniflora 13X, Hamamelis Virginiana 10X, Manganum Metallicum 10X, Ruta Graveolens 10X, Sarsaparilla 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensi. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. | Washington Homeopathic Products, Inc. | Class II | Terminated | 20211006 |
Frequently asked questions
What is Hamamelis virginiana used for?
Hemorrhoids With Bursting Sensation*
Who makes Hamamelis virginiana?
Boiron is the labeler of record for Hamamelis virginiana. 8 FDA label records share the active ingredient HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, 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 Hamamelis virginiana 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 Hamamelis virginiana 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 HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK?
Yes. 8 FDA drug label records list HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 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 Hamamelis virginiana 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.