MUSCLE THERAPY WITH ARNICA

Product NDC
54973-3085
Requested package NDC
54973-3085-2
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54973-308554973-3085-2DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3085-1GM - Gram54973-3085ff2416f1-d254-495e-9dba-69bec2eda12c12023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZWMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
BELLIS PERENNISACTIVE INGREDIENT2HU33I03UYMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNBMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587SMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
ARNICA MONTANAACTIVE MOIETYO80TY208ZWMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
BELLIS PERENNISACTIVE MOIETY2HU33I03UYMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNBMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587SMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1XMUSCLE 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 INGREDIENTX70SE62ZARMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S]2
WATERINACTIVE INGREDIENT059QF0KO0RMUSCLE 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
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3085MUSCLE THERAPY WITH ARNICA (ARNICA MONTANA, BELLIS PERENNIS, HYPERICUM PERFORATUM, LEDUM PALUSTRE TWIG, AND RUTA GRAVEOLENS FLOWERING TOP) GEL [HYLAND'S INC.]7Legacy NDC20221217_2da6e7c1-e747-4467-8f5b-1d38eeadac62.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3085-2549733085025 g in 1 PACKET (54973-3085-2) 5 g2009-01-150000-00-00NoNoCurrent