FDA.reportPublic FDA data

ARNICA MONTANA

Product NDC
65111-005
11-digit product format
651110005
Labeler code
65111
Product ID
65111-005_2d4e33f9-a89d-4305-9599-4c921226c21a
Type
HUMAN OTC DRUG
Nonproprietary name
ARNICA MONTANA
Dosage form
TABLET
Route
ORAL
Labeler
VITAMEDICA INC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-11-17
Marketing end
2026-09-08
Substance
ARNICA MONTANA
Active strength
30 [hp_X]/1
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65111-005DDiscontinued by firm2026-08-11
excluded packagepackage65111-00565111-005-66DDiscontinued by firm2026-08-11

Additional Listing Data#

Finished product
Yes
Brand name base
ARNICA MONTANA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA30 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34938425-8935-4632-8032-ba163b573ac0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65111-005-662024-02-13C16284748780-1f386c649-eb7c-0266-e053-dadaa90a7c1aDrug Facts
65111-005-662023-01-30C16284748780-1f386c649-eb7c-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65111-005-77ARNICA MONTANA1 in 1 CARTONTABLET19
65111-005-77ARNICA MONTANA30 in 1 BLISTER PACKTABLET309
65111-005-67Arnica Montana150 in 1 BOTTLETABLET1502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNICA MONTANA TABLET [VITAMEDICA INC]4
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNICA MONTANA TABLET [VITAMEDICA INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARNICA MONTANA TABLET [VITAMEDICA INC]4
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BARNICA MONTANA TABLET [VITAMEDICA INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKARNICA MONTANA TABLET [VITAMEDICA INC]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GARNICA MONTANA TABLET [VITAMEDICA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARNICA MONTANA TABLET [VITAMEDICA INC]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AARNICA MONTANA TABLET [VITAMEDICA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ARNICA MONTANA TABLET [VITAMEDICA INC]4
SORBITOLINACTIVE INGREDIENT506T60A25RARNICA MONTANA TABLET [VITAMEDICA INC]4
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RARNICA MONTANA 30X HPUS (ARNICA MONTANA,) TABLET [VITAMEDICA CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65111-005ARNICA MONTANA TABLET [VITAMEDICA INC]9Current NDC, Legacy NDC, 2 package rows20220519_34938425-8935-4632-8032-ba163b573ac0.zip
65111-005ARNICA MONTANA TABLET [VITAMEDICA CORPORATION]6Current NDC, Legacy NDC20240214_871a1ecd-19e5-4e06-a7e8-92df39716fc9.zip
65111-005ARNICA MONTANA TABLET [VITAMEDICA CORPORATION]2Current NDC, Legacy NDC, 1 package rows20220315_a134a2a4-2faa-4ef2-8af1-7f8be420f32b.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARNICA MONTANAARNICA MONTANAVITAMEDICA INC34938425-8935-4632-8032-ba163b573ac02022-05-18WarningsExact identifier
ndc (product): 65111-005
Arnica MontanaARNICA MONTANAVitamedica Corporationa134a2a4-2faa-4ef2-8af1-7f8be420f32b2022-03-14WarningsExact identifier
ndc (product): 65111-005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65111-005-6665111000566120 TABLET in 1 BOTTLE (65111-005-66) 120 tablet2014-02-130000-00-00NoNoCurrent
65111-005-6765111000567150 TABLET in 1 BOTTLE (65111-005-67) 150 tablet2021-08-122026-09-22NoNoCurrent
65111-005-77651110005771 BLISTER PACK in 1 CARTON (65111-005-77) / 30 TABLET in 1 BLISTER PACK1 blister pack2014-11-172026-09-08NoNoCurrent