FDA.reportPublic FDA data

ARNICA

Product NDC
82610-003
Requested package NDC
82610-003-14
11-digit product format
826100003
Labeler code
82610
Product ID
82610-003_d36649f0-5f18-4f81-8a19-12ef42b3509a
Type
HUMAN OTC DRUG
Nonproprietary name
ARNICA MONTANA FLOWER, CALENDULA OFFICINALIS FLOWER, HAMAMELIS VIRGINIANA LEAF, and CHAMOMILE
Dosage form
STICK
Route
TOPICAL
Labeler
ONA STICK USA LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-03-15
Marketing end
0000-00-00
Substance
ARNICA MONTANA FLOWER; CALENDULA OFFICINALIS FLOWER; CHAMOMILE; HAMAMELIS VIRGINIANA LEAF
Active strength
1 [hp_X]/14g; [hp_X]/14g; [hp_X]/14g; [hp_X]/14g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82610-00382610-003-14IInactivated by FDA2026-10-15

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82610-003-142023-07-28C16284748780-10191ceaa-7150-198a-e063-dbdaa90aec3eARNICA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82610-003-14ARNICA1 in 1 BLISTER PACKSTICK11
82610-003-14ARNICA14 g in 1 TUBESTICK141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82610-003ARNICA (ARNICA MONTANA FLOWER, CALENDULA OFFICINALIS FLOWER, HAMAMELIS VIRGINIANA LEAF, AND CHAMOMILE) STICK [ONA STICK USA LLC]1Legacy NDC, 2 package rows20220319_5eea069c-b1ee-44ed-91c1-6cd4979195ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82610-003-14826100003141 TUBE in 1 BLISTER PACK (82610-003-14) > 14 g in 1 TUBE1 tube2022-03-150000-00-00NoNoCurrent