Muscle Therapy with Arnica Pain Relief Gel

Product NDC: 54973-3203
Requested package NDC: 54973-3203-2
11-digit product format: 549733203
Labeler code: 54973
Product ID: 54973-3203_efb7ec4e-0a49-2aae-e053-2a95a90aebf2
Type: HUMAN OTC DRUG
Nonproprietary name: Arnica Montana,Bellis Perennis,Hypericum Perforatum,Ruta GraveolensFlowering Top and Rhododendron Tomentosum Leafy Twig
Dosage form: GEL
Route: TOPICAL
Labeler: Hyland
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2018-08-27
Marketing end: 0000-00-00
Substance: ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP
Active strength: 1 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54973-3203	54973-3203-2	D	Discontinued by firm		2026-10-15

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-3203	MUSCLE THERAPY WITH ARNICA PAIN RELIEF GEL (ARNICA MONTANA,BELLIS PERENNIS,HYPERICUM PERFORATUM,RUTA GRAVEOLENSFLOWERING TOP AND RHODODENDRON TOMENTOSUM LEAFY TWIG) GEL [HYLAND&RSQUO;S INC.]	6	Legacy NDC	20240927_74326a86-ff50-4597-e053-2991aa0ab959.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O80TY208ZW	ARNICA MONTANA	8057-65-6	ARNICA MONTANA
2HU33I03UY	BELLIS PERENNIS		BELLIS PERENNIS
XK4IUX8MNB	HYPERICUM PERFORATUM		HYPERICUM PERFORATUM
877L01IZ0P	RHODODENDRON TOMENTOSUM LEAFY TWIG		RHODODENDRON TOMENTOSUM LEAFY TWIG
N94C2U587S	RUTA GRAVEOLENS FLOWERING TOP		RUTA GRAVEOLENS FLOWERING TOP

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54973-3203-2	54973320302	10 g in 1 PACKET (54973-3203-2)	10 g	2018-08-27	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hyland's Muscle Therapy with Arnica Pain Relief Gel	Hyland’s Inc. \| Hyland's Inc	2024-09-25	HUMAN OTC DRUG LABEL	6