FDA.reportPublic FDA data

Arnica Montana 30X

Product NDC
68466-1042
Requested package NDC
68466-1042-2
11-digit product format
684661042
Labeler code
68466
Product ID
68466-1042_b761eb18-d7fd-4067-8d84-bb0b4c1b5268
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana
Dosage form
TABLET
Route
SUBLINGUAL; SUBLINGUAL; SUBLINGUAL
Labeler
Schwabe Mexico S.A. de C.V.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-01-01
Marketing end
2025-06-30
Substance
ARNICA MONTANA
Active strength
30 [hp_X]/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68466-104268466-1042-2DDiscontinued by firm2026-10-12

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68466-104268466-1042-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68466-104268466-1042-2DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68466-1042ARNICA MONTANA 30X (ARNICA MONTANA) TABLET [SCHWABE MEXICO S.A. DE C.V.]6Legacy NDC20201223_6ec399ba-722e-46e2-a84f-3c757d0fdd41.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68466-1042-2684661042021 BOTTLE, GLASS in 1 CARTON (68466-1042-2) > 250 TABLET in 1 BOTTLE, GLASS2006-01-012025-06-30NoNoCurrent