MUSCLE THERAPY WITH ARNICA

Product NDC: 54973-3085
Requested package NDC: 54973-3085-1
11-digit product format: 549733085
Labeler code: 54973
Product ID: 54973-3085_efb7ce0e-1be5-b164-e053-2a95a90afecf
Type: HUMAN OTC DRUG
Nonproprietary name: arnica montana, bellis perennis, hypericum perforatum, ledum palustre twig, and ruta graveolens flowering top
Dosage form: GEL
Route: TOPICAL
Labeler: Hyland's Inc.
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2009-01-15
Marketing end: 0000-00-00
Substance: ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP
Active strength: 2 [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	54973-3085	54973-3085-1	D	Discontinued by firm		2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54973-3085-1	GM - Gram	54973-3085	ff2416f1-d254-495e-9dba-69bec2eda12c	1	2023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
BELLIS PERENNIS	ACTIVE INGREDIENT	2HU33I03UY	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
HYPERICUM PERFORATUM	ACTIVE INGREDIENT	XK4IUX8MNB	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
LEDUM PALUSTRE TWIG	ACTIVE INGREDIENT	877L01IZ0P	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
RUTA GRAVEOLENS FLOWERING TOP	ACTIVE INGREDIENT	N94C2U587S	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
BELLIS PERENNIS	ACTIVE MOIETY	2HU33I03UY	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
HYPERICUM PERFORATUM	ACTIVE MOIETY	XK4IUX8MNB	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
LEDUM PALUSTRE TWIG	ACTIVE MOIETY	877L01IZ0P	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
RUTA GRAVEOLENS FLOWERING TOP	ACTIVE MOIETY	N94C2U587S	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
CHONDRUS CRISPUS	INACTIVE INGREDIENT	OQS23HUA1X	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)	INACTIVE INGREDIENT	X70SE62ZAR	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-3085	MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S INC.]	7	Legacy NDC	20221217_2da6e7c1-e747-4467-8f5b-1d38eeadac62.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
N94C2U587S	RUTA GRAVEOLENS FLOWERING TOP		RUTA GRAVEOLENS FLOWERING TOP

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54973-3085-1	54973308501	1 TUBE in 1 CARTON (54973-3085-1) > 85 g in 1 TUBE	1 tube	2009-01-15	0000-00-00	No	No	Current