FDA.reportPublic FDA data

DRUG FACTS:

Manufacturer
VITAMEDICA, INC. | Apotheca Company
Effective date
2026-06-08
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-06-11 05:11:13

Label at a glance#

ProductARNICA MONTANA 30X HPUS
Active ingredientARNICA MONTANA WHOLE
Label structure9 sections

Indications and uses

*Temporarily relieves these symptoms: • Bruising • Swelling • Pain • Stiffness • Muscle Soreness *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Do not handle the tablets. Instead, drop tablets directly under the tongue and let dissolve naturally. Adults and children 12 years and over - Take 2 tablets, 3 times a day Children under 12 years - Not intended

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 30X HPUS.**

**The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. 

PURPOSE:

OTC - PURPOSE SECTION

Arnica Montana - Bruising, swelling, pain*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiffness • Muscle Soreness

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

Ask a doctor before use if pregnant or breastfeeding.

Stop use or consult a physician if

• Any adverse reactions occur

• Symptoms persist for more than 14-days or worsen

Keep this and all medications out of reach of children.

In case of an emergency or accidental overdose, contact a medical professional or Poison Control immediately.

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

• Store at 68-77°F (20-25°C)

CONTAINS: Lactose (milk)

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• Do not handle the tablets. Instead, drop tablets directly under the tongue and let dissolve naturally.

Adults and children 12 years and over - Take 2 tablets, 3 times a day

Children under 12 years - Not intended

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Copovidone, crospovidone, lactose, magnesium stearate, mannitol, microcrystalline cellulose, silicon dioxide, and sorbitol.

QUESTIONS:

OTC - QUESTIONS SECTION

Formulated & Distributed by

VitaMedica, Inc. 

Tampa, FL 33624

888-367-8605

www.vitamedica.com

customerservice@vitamedica.com

©2026 VitaMedica, Inc.

NDC-80004-005-77

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VitaMedica

Arnica 

Montana

30X HPUS

Reduces

• Pain*

• Bruising*

• Swelling*

NATURAL REMEDY 

STIMULATES HEALING

30 Quick Dissolving

Tablets

Homeopathic Medicine

Arnica Montana 30X HPUSArnica Montana 30X HPUS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80004-00580004-005-77

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
COPOVIDONE K25-31D9C330MD8BIACT
CROSPOVIDONE2S7830E561IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITOL506T60A25RIACT
ARNICA MONTANA WHOLEO80TY208ZWACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102026-03-31full-release2026-06-01 02:38:15
92025-11-24monthly-update2026-06-03 17:37:54

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica Montana 30X HPUSARNICA MONTANAVITAMEDICA, INC.31c5546e-ee55-4cc1-b601-ce27851e47c92026-06-08WarningsExact identifier
ndc (product): 80004-005
ARNICA MONTANA 30X HPUSARNICA MONTANAVITAMEDICA, INC.40836bb5-a4a8-4fba-82ea-f9aa41cba4e62026-06-08WarningsExact identifier
ndc (package): 80004-005-77
ndc (product): 80004-005
ndc11 (package): 80004000577
spl id: 9749bb7b-059e-40e0-a7ce-193e65646aed
spl set id: 40836bb5-a4a8-4fba-82ea-f9aa41cba4e6

Reported adverse events (FAERS/openFDA)#

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