Arnica

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	53645-1001	53645-1001-2	D	Discontinued by firm		2026-10-15

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

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	ARNICA (ARNICA MONTANA) GLOBULE [TRUE BOTANICA, LLC]	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	ARNICA (ARNICA MONTANA) GLOBULE [TRUE BOTANICA, LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ARNICA (ARNICA MONTANA) GLOBULE [TRUE BOTANICA, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53645-1001	ARNICA (ARNICA MONTANA) GLOBULE [TRUE BOTANICA, LLC]	3	Legacy NDC	20230524_27e182cd-2036-41cc-a4c1-a4477c47bcbe.zip

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53645-1001-2	53645100102	23 g in 1 BOTTLE (53645-1001-2)	23 g	2013-09-02	0000-00-00	No	No	Current