FDA.reportPublic FDA data

Arnica Montana

Product NDC
53499-3571
11-digit product format
534993571
Labeler code
53499
Product ID
53499-3571_626305bd-4ae7-4180-a6b5-baf5db47c1e5
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-01-01
Marketing end
2027-03-31
Substance
ARNICA MONTANA
Active strength
30 [hp_C]/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arnica Montana

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA30 [hp_C]/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
d96936e2-7356-4404-9617-8c61c87fb5d9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3571-2Arnica Montana100 in 1 BOTTLE, GLASSTABLET10011
53499-3571-3Arnica Montana250 in 1 BOTTLE, GLASSTABLET25011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3571ARNICA MONTANA TABLET [SCHWABE NORTH AMERICA, INC.]11Current NDC, Legacy NDC, 2 package rows20220521_d96936e2-7356-4404-9617-8c61c87fb5d9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica MontanaARNICA MONTANASchwabe North America, Inc.d96936e2-7356-4404-9617-8c61c87fb5d92022-05-20WarningsExact identifier
ndc (product): 53499-3571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-3571-253499357102100 TABLET in 1 BOTTLE, GLASS (53499-3571-2) 100 tablet2006-01-012027-03-31NoNoCurrent
53499-3571-353499357103250 TABLET in 1 BOTTLE, GLASS (53499-3571-3) 250 tablet2006-01-012027-03-31NoNoCurrent