Drugplain

Calendula officinalis 12 [hp_C]/12[hp_C]

CALENDULA OFFICINALIS FLOWERING TOP · PELLET · Boiron

2 Recalls on Record
Plain English

Calendula Officinalis is an over-the-counter oral pellet made from calendula flower that is used traditionally to support wound healing and skin health. This homeopathic remedy is taken by mouth and is available without a prescription.

Key Facts

Brand Name
Calendula officinalis
Generic Name
CALENDULA OFFICINALIS FLOWERING TOP
NDC Code (Product)
0220-1063
Manufacturer
Boiron
Strength
12 [hp_C]/12[hp_C]
Dosage Form
PELLET
Route
ORAL
Marketing Status
Marketing Start
03/03/1983

Recall History

2 Recalls on Record
Class II11/08/2019

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

TerminatedVoluntary: Firm initiated
Class III04/13/2018

Boiron Inc.

Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2 reports
product use in unapproved indication2 reports
abdominal pain1 reports
acute vestibular syndrome1 reports
arrhythmia1 reports
back pain1 reports
blood pressure diastolic increased1 reports
blood testosterone increased1 reports
bradyphrenia1 reports
cerebral disorder1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Minor Wounds, Cuts Or Burns*

Dosage & Administration

1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com Info@boiron.com Distributed by Boiron, Inc. Newtown Square, PA 19073

Frequently Asked Questions

What is Calendula officinalis used for?

Calendula Officinalis is an over-the-counter oral pellet made from calendula flower that is used traditionally to support wound healing and skin health. This homeopathic remedy is taken by mouth and is available without a prescription.

Is Calendula officinalis a controlled substance?

Calendula officinalis is not classified as a controlled substance by the DEA.

What is the generic name for Calendula officinalis?

The generic name for Calendula officinalis is CALENDULA OFFICINALIS FLOWERING TOP. There are 7 other brand versions of CALENDULA OFFICINALIS FLOWERING TOP.

What is the NDC code for Calendula officinalis 12 [hp_C]/12[hp_C]?

The NDC (National Drug Code) for Calendula officinalis 12 [hp_C]/12[hp_C] is 0220-1063, listed by Boiron.

Product NDC

0220-1063

Package NDC

0220-1063-41

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)