FDA.reportPublic FDA data

Arnica Montana 200C HPUS

Product NDC
80004-009
11-digit product format
800040009
Labeler code
80004
Product ID
80004-009_b9334ab5-3aa7-4e02-a6f9-414d1614ad2e
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana
Dosage form
TABLET
Route
ORAL
Labeler
VITAMEDICA, INC.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-01-23
Substance
ARNICA MONTANA WHOLE
Active strength
200 [hp_C]/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica Montana 200C HPUSARNICA MONTANAVITAMEDICA, INC.6ae5f172-39a6-46a9-b374-02f8c7e9d0682026-01-23WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS: 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. CONTAINS: Lactose (milk) • Do not use if seal is broken or shows any signs of tampering. • Store at 68-77°F (20-25°C)

Additional Listing Data#

Finished product
Yes
Brand name base
Arnica Montana 200C HPUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA WHOLE200 [hp_C]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO80TY208ZW

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80004-009-20Arnica Montana 200C HPUS150 in 1 BOTTLETABLET1501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80004-009-2080004000920150 TABLET in 1 BOTTLE (80004-009-20) 150 tablet2026-01-23NoNoCurrent