Arnica Montana
- Product NDC
- 53499-3533
- 11-digit product format
- 534993533
- Labeler code
- 53499
- Product ID
- 53499-3533_a1540a26-52e7-4f53-896a-10858c0102b2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Arnica Montana
- Dosage form
- TABLET
- Route
- SUBLINGUAL
- Labeler
- Schwabe North America
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2006-01-01
- Marketing end
- 2025-10-31
- Substance
- ARNICA MONTANA
- Active strength
- 6 [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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53499-3533 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 53499-3533 | 53499-3533-2 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 53499-3533 | 53499-3533-3 | D | Discontinued by firm | 2026-10-15 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53499-3533-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53499-3533-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53499-3533-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53499-3533-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53499-3533-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53499-3533-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53499-3533-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53499-3533-2 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53499-3533-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53499-3533-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53499-3533-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53499-3533-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53499-3533-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ARNICA MONTANA | ACTIVE INGREDIENT | O80TY208ZW | ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO] | 2 | |
| ARNICA MONTANA | ACTIVE MOIETY | O80TY208ZW | ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ARNICA MONTANA TABLET [NATURE'S WAY HOLDING CO] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53499-3533 | ARNICA MONTANA (ARNICA MONTANA) TABLET [SCHWABE NORTH AMERICA] | 8 | Legacy NDC | 20201013_670f4cf3-e59f-4927-8257-23befc539281.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53499-3533-3 | 53499353303 | 1 BOTTLE, GLASS in 1 CARTON (53499-3533-3) > 250 TABLET in 1 BOTTLE, GLASS | 2006-01-01 | 2025-10-31 | No | No | Current |