Arnica Montana

Product NDC: 53499-3533
Requested package NDC: 53499-3533-3
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
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.

Historic NDC status page 1 of 1 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53499-3533	53499-3533-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 table
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O80TY208ZW	ARNICA MONTANA	8057-65-6	ARNICA MONTANA

Packages#

Package NDC, 11-digit format, Description table
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Arnica Montana 6X	Schwabe North America \| Schwabe Mexico, S.A. de C.V.	2020-10-12	HUMAN OTC DRUG LABEL	8