FDA.reportPublic FDA data

Arnicare Tablets

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:32:42

Label at a glance#

ProductArnicare Arnica
Active ingredientARNICA MONTANA
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient** (in each tablet)

Arnica Montana 9C HPUS (2.5 mg)

The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Arnica montana 9C HPUS (2.5 mg) ... Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves minor muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as:
  • pain
  • swelling
  • discoloration

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

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. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 6 years of age or older - At the onset of symptoms, dissolve 2 tablets under the tongue and repeat every hour for 2 more hours. Then, dissolve 2 tablets under the tongue every 6 hours until symptoms are relieved.

Children 2 to 5 years of age - Dissolve 2 tablets in 1 tablespoon for easier intake. Follow directions above.

Children under 2 years of age - Ask a doctor.

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, magnesium, stearate

SPL UNCLASSIFIED SECTION

  • do not use if glued carton end flaps are open or if the blister seal is broken
  • store below 86°F (30°C)

No known drug interactions

Pain Relief*

Swelling & Bruise from Injuries Muscle Pain*

Gentle on the Stomach

NSAID-Free

60 Meltaway Tablets unflavored

100 Meltawat Tablets unflavored

120 Meltaway Tablets unflavored

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

OTC - QUESTIONS SECTION

Questions or Comments?

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1
(1-800-264-7661)

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

120120

LABELLABEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9059-042023-07-18C16284748780-1f386c64a-26b0-0266-e053-dadaa90a7c1aArnicare Tablets
0220-9059-292023-07-18C16284748780-1f386c64a-26b0-0266-e053-dadaa90a7c1aArnicare Tablets
0220-9059-042023-01-30C16284748780-1f386c64a-26b0-0266-e053-dadaa90a7c1aArnicare Tablets
0220-9059-292023-01-30C16284748780-1f386c64a-26b0-0266-e053-dadaa90a7c1aArnicare Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9059-04Arnicare Arnica60 in 1 BLISTER PACKTABLET6010
0220-9059-29Arnicare Arnica120 in 1 BLISTER PACKTABLET12010
0220-9059-92Arnicare Arnica100 in 1 BLISTER PACKTABLET10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9059ARNICARE ARNICA (ARNICA MONTANA) TABLET [LABORATOIRES BOIRON]10Current NDC, Legacy NDC, 3 package rows20250323_96a3e7ea-94ed-46b4-94d7-70b8cc68c688.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-9059-04EA - Each0220-905937f517f3-3f9e-4dc3-9755-0d3a4535dbb512021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW4
ARNICA MONTANAACTIVE MOIETYO80TY208ZW4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH484
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I304

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90590220-9059-04, 0220-9059-29, 0220-9059-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
ARNICA MONTANAO80TY208ZWACTIB

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
4 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnicare ArnicaARNICA MONTANALaboratoires Boiron96a3e7ea-94ed-46b4-94d7-70b8cc68c6882025-03-20Exact identifier
ndc (package): 0220-9059-04
ndc (package): 0220-9059-92
ndc (package): 0220-9059-29
ndc (product): 0220-9059
ndc11 (package): 00220905904
ndc11 (package): 00220905929
ndc11 (package): 00220905992
spl id: 30d0f65b-a256-29b9-e063-6394a90a9b0f
spl set id: 96a3e7ea-94ed-46b4-94d7-70b8cc68c688

Reported adverse events (FAERS/openFDA)#

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