ARNICA MONTANA

Manufacturer: Hyland's Inc.
Effective date: 2022-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 21:44:36

Label at a glance#

ProductARNICA MONTANA

Active ingredientARNICA MONTANA

Label structure11 sections

Indications and uses

Bruises or Muscle Soreness

Dosage and administration

Adults: Dissolve 4 tablets under tongue 4 times a day. Children: consult a healthcare professional.

Contacts and useful links#

PhoneLabel contact800-624-9659

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Bruises or Muscle Soreness

OTC - ACTIVE INGREDIENT SECTION

ARNICA MONTANA 6X

INDICATIONS & USAGE SECTION

Bruises or Muscle Soreness

SPL UNCLASSIFIED SECTION

Made according to the Homeopathic Pharmacopoeia of the United States since 1903.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if cap band is missing or broken.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or nursing, consult a licensed health care professional before using this product.

OTC - ASK DOCTOR/PHARMACIST SECTION

If symptoms persist for 7 days or worsen, contact a licensed practitioner.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of the reach of children.

OTC - WHEN USING SECTION

To be used according to label indications and/or standard homeopathic indications.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: Dissolve 4 tablets under tongue 4 times a day.

Children: consult a healthcare professional.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum and Lactose

Questions?

OTC - QUESTIONS SECTION

800-624-9659

Indications and Usage

RECENT MAJOR CHANGES SECTION

Bruises or Muscle Soreness

Dosage and Administration

RECENT MAJOR CHANGES SECTION

Adults: Dissolve 4 tablets under tongue 4 times a day.

Children: consult a healthcare professional.

PRINCIPAL DISPLAY PANEL - 250 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SINCE 1903
Hyland's ^®
HOMEOPATHIC

NDC 54973-0604-4

ARNICA
MONTANA
6X

BRUISES OR MUSCLE
SORENESS*

250 TABLETS

*Claims are based on traditiona

l homeopathic practice, not

accepted medical evidence.

Not FDA evaluated.

label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1

Products#

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

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

ARNICA MONTANA
ACACIA
LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-0604	54973-0604-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACACIA	5C5403N26O	IACT
LACTOSE	J2B2A4N98G	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 · 55 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / INTRAMUSCULAR	1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, COATED / ORAL	156 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SYRUP / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / ORAL	70 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	GUM, CHEWING / BUCCAL		280 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, CHEWABLE / ORAL		121 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / SUBLINGUAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / BUCCAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii candidate 19 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
2c4044c4-076b-c0ac-e063-6394a90ab577			f35c6450-face-4855-b559-69aea8fb478f	2025-01-21	Warnings	Exact identifier spl set id: f35c6450-face-4855-b559-69aea8fb478f

Reported adverse events (FAERS/openFDA)#

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