FDA.reportPublic FDA data

Arnica

Product NDC
53645-1002
11-digit product format
536451002
Labeler code
53645
Product ID
53645-1002_f03195c6-13dd-067a-e053-2a95a90ac213
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana
Dosage form
GLOBULE
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-09-02
Marketing end
0000-00-00
Substance
ARNICA MONTANA
Active strength
6 [hp_X]/23g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53645-1002DDiscontinued by firm2026-10-12
excluded packagepackage53645-100253645-1002-2DDiscontinued by firm2026-10-12

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
53645-1002ARNICA (ARNICA MONTANA) GLOBULE [TRUE BOTANICA, LLC]4Legacy NDC20230621_9c8a36f8-2746-57ee-e053-2a95a90a3c14.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1002-25364510020223 g in 1 BOTTLE (53645-1002-2) 23 g2013-09-020000-00-00NoNoCurrent