FDA.reportPublic FDA data

Arnica Plus

Product NDC
43846-0075
Requested package NDC
43846-0075-1
11-digit product format
438460075
Labeler code
43846
Product ID
43846-0075_8c022804-3556-4ec1-a554-175f50272762
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana, Hamamelis Virginiana, Rhus Tox
Dosage form
GEL
Route
TOPICAL
Labeler
Peaceful Mountain, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-11-14
Marketing end
0000-00-00
Substance
ARNICA MONTANA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; TOXICODENDRON PUBESCENS LEAF
Active strength
6 [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43846-007543846-0075-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-07DRUG FACTS:
2023-08-07DRUG FACTS:
2023-01-30DRUG FACTS:
2023-01-30DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43846-0075-1Arnica Plus57 g in 1 TUBEGEL574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43846-0075ARNICA PLUS (ARNICA MONTANA, HAMAMELIS VIRGINIANA, RHUS TOX) GEL [PEACEFUL MOUNTAIN, INC.]4Legacy NDC, 1 package rows20230808_613ddf6c-ba89-4b98-8576-d2cd38f6910a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43846-0075-14384600750157 g in 1 TUBE (43846-0075-1) 57 g2018-11-140000-00-00NoNoCurrent