FDA.reportPublic FDA data

ARNICA MONTANA 30C - 3-PACK

Manufacturer
SEVENE USA
Effective date
2025-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:33:32

Label at a glance#

ProductARNICA MONTANA 30C - 3-PACK
Active ingredientARNICA MONTANA
Label structure12 sections

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF ARNICA MONTANA 30c

TRADITIONALLY USED FOR

INDICATIONS & USAGE SECTION

Pain from muscle soreness, stiffness, swelling - bruises*

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USE

OTC - PURPOSE SECTION

Condition listed above or as directed by a physician.

WARNINGS

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature.

DO NOT USE

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INCACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose.

QUESTIONS?

OTC - QUESTIONS SECTION

info@ollois.com * www.ollois.com * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARNICA 30C 3P P1ARNICA 30C 3P P1ARNICA 30C 3P P2ARNICA 30C 3P P2ARNICA 30C 3P P3ARNICA 30C 3P P3ETUI ARNICA 30C 3P P1ETUI ARNICA 30C 3P P1ETUI ARNICA 30C 3P P2ETUI ARNICA 30C 3P P2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-5000-1ARNICA MONTANA 30C - 3-PACK80 in 1 CYLINDERPELLET803
76472-5000-2ARNICA MONTANA 30C - 3-PACK3 in 1 BOXPELLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-5000ARNICA MONTANA 30C - 3-PACK (ARNICA MONTANA) PELLET [SEVENE USA]3Current NDC, 2 package rows20250516_2cef6a91-d300-18e6-e063-6394a90ab88f.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-500076472-5000-1, 76472-5000-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
ARNICA MONTANAO80TY208ZWACTIB

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
ARNICA MONTANA 30C - 3-PACKARNICA MONTANASEVENE USA2cef6a91-d300-18e6-e063-6394a90ab88f2025-05-15WarningsExact identifier
ndc (package): 76472-5000-2
ndc (package): 76472-5000-1
ndc (product): 76472-5000
ndc11 (package): 76472500002
ndc11 (package): 76472500001
spl id: 352bf2f7-a0e9-3be3-e063-6394a90ab028
spl set id: 2cef6a91-d300-18e6-e063-6394a90ab88f

Reported adverse events (FAERS/openFDA)#

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