FDA.reportPublic FDA data

Arnica montana

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:56

Label at a glance#

ProductArnica montana
Active ingredientARNICA MONTANA
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth, (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 30c

OTC - PURPOSE SECTION

Trauma; Injuries; Bruises; Exhaustion; Headache; Sprains; Wounds

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose free) pellets

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

Warning:Keep out of reach of children. Do not use if tamper - evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-9009-1Arnica montana28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-9009ARNICA MONTANA (ACONITUM NAPELLUS) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250212_9e3be074-b2cd-9b1f-e053-2a95a90ac7b2.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
55714-900955714-9009-1

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
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 montanaACONITUM NAPELLUSNewton Laboratories, Inc.9e3be074-b2cd-9b1f-e053-2a95a90ac7b22025-02-10WarningsExact identifier
ndc (package): 55714-9009-1
ndc (product): 55714-9009
ndc11 (package): 55714900901
spl id: 2dd2175c-db3f-4df9-e063-6394a90a5e84
spl set id: 9e3be074-b2cd-9b1f-e053-2a95a90ac7b2

Reported adverse events (FAERS/openFDA)#

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