FDA.reportPublic FDA data

Arnica Montana

Manufacturer
Vitamedica Corporation | Apotheca Company
Effective date
2022-03-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:17:09

Label at a glance#

ProductArnica Montana
Active ingredientARNICA MONTANA
Label structure9 sections

Dosage and administration

Adults, three tablets, three times a day. Not intended for children under 12 years of age. This product is a sublingual application.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 30X.

PURPOSE:

OTC - PURPOSE SECTION

Anti-Inflammatory

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding ask a health professional before use. Discontinue use if any adverse reactions occur. Contact your physician, if symptoms do not subside within 14 days.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if seal is broken or shows any signs of tampering.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults, three tablets, three times a day. Not intended for children under 12 years of age. This product is a sublingual application.

INDICATION:

INDICATIONS & USAGE SECTION

Anti-Inflammatory

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Copovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Silicon Dioxide, and Sorbitol.

QUESTIONS:

OTC - QUESTIONS SECTION

Formulated and Distributed

by VitaMedica Corp.

Torrance, CA 90502

888-367-8605 VitaMedica.com

©2021 VitaMedica Corporation

NDC 65111-005-67

PACKAGE DISPLAY LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VitaMedica

Arnica Montana

30X HPUS

REDUCES

Bruising, Swelling & Pain

NATURAL REMEDY

STIMULATES HEALING

Recommended by Plastic Surgeons

Homeopathic Medicine

150 Sublingual Tablets

Arnica Montana 30X HPUSArnica Montana 30X HPUS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65111-005-67Arnica Montana150 in 1 BOTTLETABLET1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65111-005ARNICA MONTANA TABLET [VITAMEDICA CORPORATION]2Legacy NDC, 1 package rows20220315_a134a2a4-2faa-4ef2-8af1-7f8be420f32b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65111-00565111-005-67

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARNICA MONTANAO80TY208ZWACTIB
COPOVIDONE K25-31D9C330MD8BIACT
CROSPOVIDONE2S7830E561IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b3fc45c7-c208-4194-82a2-ad311dce494ea134a2a4-2faa-4ef2-8af1-7f8be420f32b2022-03-14WarningsExact identifier
spl id: b3fc45c7-c208-4194-82a2-ad311dce494e
spl set id: a134a2a4-2faa-4ef2-8af1-7f8be420f32b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.