FDA.reportPublic FDA data

ARNICA MONTANA

Product NDC
15631-2600
11-digit product format
156312600
Labeler code
15631
Product ID
15631-2600_140161f5-6181-8b0c-e063-6294a90a0aa0
Type
HUMAN OTC DRUG
Nonproprietary name
ARNICA MONTANA
Dosage form
LIQUID
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-03-19
Substance
ARNICA MONTANA
Active strength
3 [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ARNICA MONTANA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA3 [hp_X]/mL

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
14018b2a-6862-35cf-e063-6394a90a5cf6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-2600-0ARNICA MONTANA10 mL in 1 BOTTLELIQUID101
15631-2600-1ARNICA MONTANA30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-2600ARNICA MONTANA LIQUID [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1Current NDC, 2 package rows20240320_14018b2a-6862-35cf-e063-6394a90a5cf6.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 MONTANARxhomeo Private Limited d.b.a. Rxhomeo, Inc14018b2a-6862-35cf-e063-6394a90a5cf62024-03-19WarningsExact identifier
ndc (product): 15631-2600

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15631-2600-01563126000010 mL in 1 BOTTLE (15631-2600-0) 10 ml2024-03-19NoNoCurrent
15631-2600-11563126000130 mL in 1 BOTTLE (15631-2600-1) 30 ml2024-03-19NoNoCurrent