Drugplain

Arnica 30 [hp_C]/1

ARNICA MONTANA · PELLET · Laboratoires Boiron

10 Recalls on Record
Plain English

Arnica Montana is an herbal remedy taken by mouth as pellets that is commonly used to help reduce bruising and promote healing after injuries or surgery. This over-the-counter product is based on the arnica plant and is used by some people to manage minor pain and swelling.

Key Facts

Brand Name
Arnica
Generic Name
ARNICA MONTANA
NDC Code (Product)
0220-0508
Manufacturer
Laboratoires Boiron
Strength
30 [hp_C]/1
Dosage Form
PELLET
Route
ORAL
Marketing Status
Marketing Start
05/01/2009

Recall History

10 Recalls on Record
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated
Class II06/05/2023

Homeocare Laboratories, Inc.

cGMP deviations

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II06/21/2019

Pharma-Natural Inc.

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

TerminatedVoluntary: Firm initiated
Class II04/15/2025

Pharmadel, LLC

cGMP deviations

TerminatedVoluntary: Firm initiated
Class I07/20/2018

King Bio Inc.

Microbial contamination

TerminatedVoluntary: Firm initiated
Class II08/20/2021

Washington Homeopathic Products, Inc.

Out-of-specification test results obtained for identification testing based on HPTLC analysis.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective747 reports
macular degeneration589 reports
pain515 reports
off label use474 reports
constipation456 reports
nausea394 reports
pyrexia344 reports
headache327 reports
malaise317 reports
weight decreased295 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: Temporarily relieves pain, swelling, and discoloration associated with: Bruises Minor falls Sports injuries Muscle soreness

Dosage & Administration

Directions: Apply a thin layer to the affected area 2 to 3 times daily. Gently massage until absorbed. Use as soon as possible after minor injury.

Warnings

For external use only Do not apply to broken skin or open wounds. Avoid contact with eyes. When using this product Avoid contact with eyes. Stop use and ask a doctor if Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding Ask a health professional before use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Arnica used for?

Arnica Montana is an herbal remedy taken by mouth as pellets that is commonly used to help reduce bruising and promote healing after injuries or surgery. This over-the-counter product is based on the arnica plant and is used by some people to manage minor pain and swelling.

Is Arnica a controlled substance?

Arnica is not classified as a controlled substance by the DEA.

What is the generic name for Arnica?

The generic name for Arnica is ARNICA MONTANA. There are 12 other brand versions of ARNICA MONTANA.

What is the NDC code for Arnica 30 [hp_C]/1?

The NDC (National Drug Code) for Arnica 30 [hp_C]/1 is 0220-0508, listed by Laboratoires Boiron.