Digitalis purpurea

DIGITALIS ORAL HUMAN PRESCRIPTION DRUG

Digitalis purpurea is an FDA drug label for the active ingredient DIGITALIS 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
DIGITALIS
Manufacturer
Boiron
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Dosage form
N/A
NDC
0220-1767
Application
N/A
Label effective
20231113

About this product

Digitalis purpurea is an FDA-registered drug product whose active ingredient is DIGITALIS. It is labelled by Boiron taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0220-1767, label effective 20231113. It is one of 5 FDA drug label records sharing the active ingredient DIGITALIS. 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.

Active ingredients

Digitalis purpurea 6X (**contains 0.443 mg of the active ingredient per pellet)

Indications & Usage

Rx Only*

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 DIGITALIS compare

FDA lists 5 drug label records with DIGITALIS 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 5
— — — —
— — — —
— — — —
— — — —

Recall and safety notices

3 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-0881-2021 ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Crataegus Oxyacantha 10X, Baryta Carbonica 10X, Digitalis Purpurea 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. RX Only, Manufactured by Washington Homeopathic Products, Inc. 260 JR Hawvermale Way, Berkeley Springs, WV, 25411. Washington Homeopathic Products, Inc. Class II Terminated 20211006
D-0882-2021 Z-1020 Formula. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine, For Manufacturing Use Only, REMEDY: Aurum Metallicum 10X, Baryta Carbonica 10X, Chromium Sulphuricum 10X, Crataegus Oxyacantha 10X, Digitalis Purpurea 10X, Manganum Metallicum 10X, Zincum Muriaticum 13X, Dilution Alcohol 20%. Manufactured for Optimal Health Dimensions. 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 Digitalis purpurea used for?
Rx Only*

Who makes Digitalis purpurea?
Boiron is the labeler of record for Digitalis purpurea. 5 FDA label records share the active ingredient DIGITALIS, 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 Digitalis purpurea 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 Digitalis purpurea prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIGITALIS?
Yes. 5 FDA drug label records list DIGITALIS 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 Digitalis purpurea been recalled?
3 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.