Advanced Arnica Plus

Product NDC
57955-2803
Requested package NDC
57955-2803-2
11-digit product format
579552803
Labeler code
57955
Product ID
57955-2803_c9f04cc2-a78b-4e5c-8c2e-9440bcf14b9c
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica montana, Arnica montana, radix, Bellis perennis, Bryonia, Hypericum perforatum, Lithium carbonicum, Magnesia phosphorica, Phytolacca decandra, Rhus tox, Ruta graveolens
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-09-26
Marketing end
0000-00-00
Substance
ARNICA MONTANA ROOT; ARNICA MONTANA WHOLE; BELLIS PERENNIS WHOLE; BRYONIA ALBA ROOT; HYPERICUM PERFORATUM WHOLE; LITHIUM CARBONATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF
Active strength
10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Mood Stabilizer [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 packagepackage57955-280357955-2803-2DDiscontinued by firm2026-10-15

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 · 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 packagepackage57955-280357955-2803-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57955-280357955-2803-2DDiscontinued 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
57955-2803ADVANCED ARNICA PLUS (ARNICA MONTANA, ARNICA MONTANA, RADIX, BELLIS PERENNIS, BRYONIA, HYPERICUM PERFORATUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, PHYTOLACCA DECANDRA, RHUS TOX, RUTA GRAVEOLENS) LIQUID [KING BIO INC.]5Legacy NDC20250522_e64731dd-a810-4157-b6f2-73fe2197cfdb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57955-2803-2579552803021 BOTTLE, SPRAY in 1 CARTON (57955-2803-2) > 59 mL in 1 BOTTLE, SPRAY2022-09-260000-00-00NoNoCurrent