ARNICA MONTANA

Manufacturer: SEVENE USA
Effective date: 2025-02-10
Label type: HUMAN OTC DRUG LABEL
Version: 25
Source: full-release
Hydrated at: 2026-06-01 02:31:53

Label at a glance#

ProductARNICA MONTANA

Active ingredientARNICA MONTANA

Label structure13 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.

Contacts and useful links#

Websitewww.ollois.com

www.ollois.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Homeopathic dilution of HPUS Arnica Montana 200ck

PURPOSE

OTC - PURPOSE SECTION

Pain from muscle soreness, stiffness, swelling - Bruises*

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

INDICATIONS & USAGE 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose.

QUESTIONS?

OTC - QUESTIONS SECTION

www.ollois.com * info@ollois.com * Made in France. Not reviewed by the FDA and not guaranteed to be effective. This homepathic dilution may not be suseptible to scientific measurement.

USE:

RECENT MAJOR CHANGES SECTION

Condition listed above or as directed by a physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARNICA MONTANA 200ck

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76472-1128-1	2025-02-10	C162847	48780-1	2cef2736-76c1-d83d-e063-dadaa90ab31f	Sevene USA (as PLD) - ARNICA MONTANA 200ck (76472-1128)
76472-1128-1	2025-01-30	C162847	48780-1	2cef2736-76c1-d83d-e063-dadaa90ab31f	Sevene USA (as PLD) - ARNICA MONTANA 200ck (76472-1128)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76472-1128-1	ARNICA MONTANA	80 in 1 CYLINDER	PELLET	80		25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76472-1128	ARNICA MONTANA PELLET [SEVENE USA]	25	Current NDC, Legacy NDC, 1 package rows	20250212_5e840b32-ea22-437f-acd9-46011733e643.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	4
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	4
sucrose	INACTIVE INGREDIENT	C151H8M554	4

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

ARNICA MONTANA
SUCROSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76472-1128	76472-1128-1

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
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
ARNICA MONTANA	O80TY208ZW	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii+route 2 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii+route 2 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARNICA MONTANA	ARNICA MONTANA	SEVENE USA	5e840b32-ea22-437f-acd9-46011733e643	2025-02-10	Warnings	Exact identifier ndc (package): 76472-1128-1 ndc (product): 76472-1128 ndc11 (package): 76472112801 spl id: 2dcc540d-ce90-d0a7-e063-6294a90a646c spl set id: 5e840b32-ea22-437f-acd9-46011733e643

Reported adverse events (FAERS/openFDA)#

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