Hydrastis candadensis

Hydrastis candadensis is an FDA-registered drug product whose active ingredient is GOLDENSEAL. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-2550, label effective 20231221. It is one of 11 FDA drug label records sharing the active ingredient GOLDENSEAL. 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.

Across FDA labelling, products containing GOLDENSEAL are most often described in connection with: post-nasal drip. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Post-Nasal Drip*

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.

FDA lists 11 drug label records with GOLDENSEAL 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.

1 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.

What is Hydrastis candadensis used for?
Post-Nasal Drip*

Who makes Hydrastis candadensis?
Boiron is the labeler of record for Hydrastis candadensis. 11 FDA label records share the active ingredient GOLDENSEAL, 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 Hydrastis candadensis 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 Hydrastis candadensis 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 GOLDENSEAL?
Yes. 11 FDA drug label records list GOLDENSEAL 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 Hydrastis candadensis been recalled?
1 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.