BACKACHE WITH ARNICA

Manufacturer: Hyland's | Standard Homeopathic Company
Effective date: 2019-11-22
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 23:57:52

Label at a glance#

ProductBACKACHE WITH ARNICA

Active ingredientBENZOIC ACID, COLCHICUM AUTUMNALE BULB, SULFUR, ARNICA MONTANA, TOXICODENDRON PUBESCENS LEAF

Label structure8 sections

Dosage and administration

For adults and children over 12 years of age: Dissolve 2-3 tablets under the tongue every 4 hours or as needed.

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Hyland's ^® BackAche is a traditional homeopathic formula for the relief of symptoms of pains in the lower back due to strain, overexertion, cold or exposure. Hyland's BackAche contains Arnica Montana which is the most commonly used homeopathic medicine for relief of muscular pain. Hyland's BackAche works without contraindications or side effects to relieve symptoms naturally. This product is a gentle, safe medication that may be used in conjunction with other medications.

Indications

INDICATIONS & USAGE SECTION

A homeopathic medicine for the temporary relief of symptoms of low back pain due to strain or overexertion.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children over 12 years of age: Dissolve 2-3 tablets under the tongue every 4 hours or as needed.

OTC - ACTIVE INGREDIENT SECTION

FORMULA

INACTIVE INGREDIENT SECTION

BENZOICUM ACIDUM 3X HPUS, COLCHICUM AUTUMNALE 3X HPUS, SULPHUR 3X HPUS, ARNICA MONTANA 6X HPUS, RHUS TOXICODENDRON 6X HPUS IN A BASE OF LACTOSE, N.F.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if imprinted cap band is broken or missing.

OTC - ASK DOCTOR/PHARMACIST SECTION

If symptoms persist for more than 7 days or worsen, consult a licensed health care professional.

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are pregnant or nursing a baby, seek the advice of a licensed health care professional before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a poison control center immediately. In case of emergency, the manufacturer may be reached 24 hours a day, 7 days a week at 800/624-9659.

SPL UNCLASSIFIED SECTION

HYLAND'S INC.
LOS ANGELES, CA 90061

QUESTIONS?

OTC - QUESTIONS SECTION

CALL US: 800/624-9659

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-2965-1

Hyland's^®
HOMEOPATHIC

BACKACHE
WITH ARNICA

Fast Symptomatic Relief
for Low Back Pain.

100
TABLETS

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	1
BENZOIC ACID	ACTIVE INGREDIENT	8SKN0B0MIM	1
COLCHICUM AUTUMNALE BULB	ACTIVE INGREDIENT	993QHL78E6	1
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE INGREDIENT	6IO182RP7A	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	1
BENZOIC ACID	ACTIVE MOIETY	8SKN0B0MIM	1
COLCHICUM AUTUMNALE BULB	ACTIVE MOIETY	993QHL78E6	1
SULFUR	ACTIVE MOIETY	70FD1KFU70	1
TOXICODENDRON PUBESCENS LEAF	ACTIVE MOIETY	6IO182RP7A	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

BACKACHE WITH ARNICA
BENZOIC ACID, COLCHICUM AUTUMNALE BULB, SULFUR, ARNICA MONTANA, and TOXICODENDRON PUBESCENS LEAF
LACTOSE
BENZOIC ACID
COLCHICUM AUTUMNALE BULB
SULFUR
ARNICA MONTANA
TOXICODENDRON PUBESCENS LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-2965	54973-2965-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE	J2B2A4N98G	IACT
BENZOIC ACID	8SKN0B0MIM	ACTIB
COLCHICUM AUTUMNALE BULB	993QHL78E6	ACTIB
SULFUR	70FD1KFU70	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
TOXICODENDRON PUBESCENS LEAF	6IO182RP7A	ACTIB

Source Document#

Source XML · Source PDF

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 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	CAPSULE, COATED PELLETS / ORAL	135.2 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	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		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	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 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	POWDER / VAGINAL	430 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	CREAM / VAGINAL	3 %w/w		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	CAPSULE, EXTENDED RELEASE / ORAL	120 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	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 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
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		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
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 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	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		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
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 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	OINTMENT / TOPICAL	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
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		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	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 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	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 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

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
d4285e84-4137-f07b-e053-2a95a90a54d8			f25f2a26-bddf-49bb-b1bc-084ce86f00cb	2021-12-27	Warnings	Exact identifier spl set id: f25f2a26-bddf-49bb-b1bc-084ce86f00cb

Reported adverse events (FAERS/openFDA)#

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