FDA.reportPublic FDA data

ARNICA MONTANA

Product NDC
15631-0049
11-digit product format
156310049
Labeler code
15631
Product ID
15631-0049_ca3a76f4-9778-f398-e053-2995a90a240e
Type
HUMAN OTC DRUG
Nonproprietary name
ARNICA MONTANA
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-09-07
Substance
ARNICA MONTANA
Active strength
3 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage15631-0049-3
excluded packagepackage15631-0049-1
excluded packagepackage15631-0049-5
excluded packagepackage15631-0049-4
excluded packagepackage15631-0049-2
excluded packagepackage15631-0049-0

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]/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
de6636fd-aa9a-4283-8af9-4c6520a5dfb5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
15631-0049-02020-02-17de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-12020-02-17de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-22020-02-17de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-32020-02-17de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-42020-02-17de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-52020-02-17de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-02020-01-31de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-12020-01-31de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-22020-01-31de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-32020-01-31de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-42020-01-31de6636fd-aa9a-4283-8af9-4c6520a5dfb5
15631-0049-52020-01-31de6636fd-aa9a-4283-8af9-4c6520a5dfb5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0049-0ARNICA MONTANA100 in 1 PACKAGEPELLET1003
15631-0049-1ARNICA MONTANA200 in 1 PACKAGEPELLET2003
15631-0049-2ARNICA MONTANA400 in 1 PACKAGEPELLET4003
15631-0049-3ARNICA MONTANA750 in 1 PACKAGEPELLET7503
15631-0049-4ARNICA MONTANA2500 in 1 PACKAGEPELLET25003
15631-0049-5ARNICA MONTANA12500 in 1 PACKAGEPELLET125003
15631-0049-6ARNICA MONTANA500 in 1 PACKAGEPELLET5003
15631-0049-7ARNICA MONTANA1000 in 1 PACKAGEPELLET10003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWARNICA MONTANA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
ARNICA MONTANAACTIVE MOIETYO80TY208ZWARNICA MONTANA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554ARNICA MONTANA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0049ARNICA MONTANA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]3Current NDC, Legacy NDC, 8 package rows20210824_de6636fd-aa9a-4283-8af9-4c6520a5dfb5.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, Incde6636fd-aa9a-4283-8af9-4c6520a5dfb52021-08-23WarningsExact identifier
ndc (product): 15631-0049

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0049-015631004900100 PELLET in 1 PACKAGE (15631-0049-0) 100 pellet2018-01-010000-00-00NoNoCurrent
15631-0049-115631004901200 PELLET in 1 PACKAGE (15631-0049-1) 200 pellet2018-01-010000-00-00NoNoCurrent
15631-0049-215631004902400 PELLET in 1 PACKAGE (15631-0049-2) 400 pellet2018-01-010000-00-00NoNoCurrent
15631-0049-315631004903750 PELLET in 1 PACKAGE (15631-0049-3) 750 pellet2018-01-010000-00-00NoNoCurrent
15631-0049-4156310049042500 PELLET in 1 PACKAGE (15631-0049-4) 2500 pellet2018-01-010000-00-00NoNoCurrent
15631-0049-51563100490512500 PELLET in 1 PACKAGE (15631-0049-5) 12500 pellet2018-01-010000-00-00NoNoCurrent
15631-0049-615631004906500 PELLET in 1 PACKAGE (15631-0049-6) 500 pellet2021-08-230000-00-00NoNoCurrent
15631-0049-7156310049071000 PELLET in 1 PACKAGE (15631-0049-7) 1000 pellet2021-08-230000-00-00NoNoCurrent