FDA.reportPublic FDA data

Hylands Leg Cramps With Arnica

Product NDC
54973-4126
11-digit product format
549734126
Labeler code
54973
Product ID
54973-4126_38fa5966-3bea-3f0b-e063-6394a90a72db
Type
HUMAN OTC DRUG
Nonproprietary name
ACONITUM NAPELLUS
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Consumer Health Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-03-21
Substance
ACONITUM NAPELLUS; ARNICA MONTANA WHOLE; CINCHONA BARK; LEDUM PALUSTRE TWIG; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF
Active strength
5; 5; 2; 2; 2; 5 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hylands Leg Cramps With ArnicaACONITUM NAPELLUSHyland's Consumer Health Inc.142ea9b2-63f9-6a04-e063-6394a90a7fc92025-07-02WarningsExact identifier
ndc (product): 54973-4126

Additional Listing Data#

Finished product
Yes
Brand name base
Hylands Leg Cramps With Arnica
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOXICODENDRON PUBESCENS LEAF5 [hp_X]/1
CINCHONA BARK5 [hp_X]/1
PSEUDOGNAPHALIUM OBTUSIFOLIUM2 [hp_X]/1
LEDUM PALUSTRE TWIG2 [hp_X]/1
ARNICA MONTANA WHOLE2 [hp_X]/1
ACONITUM NAPELLUS5 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6IO182RP7AInternal UNII lookup
292E43P4I9Internal UNII lookup
36XQ854NWWInternal UNII lookup
877L01IZ0PInternal UNII lookup
O80TY208ZWInternal UNII lookup
U0NQ8555JDInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
142ea9b2-63f9-6a04-e063-6394a90a7fc9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4126-1Hylands Leg Cramps With Arnica100 in 1 CARTONTABLET1006
54973-4126-2Hylands Leg Cramps With Arnica40 in 1 CARTONTABLET406
54973-4126-3Hylands Leg Cramps With Arnica16 in 1 CARTONTABLET166

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4126HYLANDS LEG CRAMPS WITH ARNICA (ACONITUM NAPELLUS) TABLET [HYLAND'S CONSUMER HEALTH INC.]5Current NDC, 3 package rows20250321_142ea9b2-63f9-6a04-e063-6394a90a7fc9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54973-4126-154973412601100 TABLET in 1 CARTON (54973-4126-1) 100 tablet2024-03-21NoNoCurrent
54973-4126-25497341260240 TABLET in 1 CARTON (54973-4126-2) 40 tablet2024-03-21NoNoCurrent
54973-4126-35497341260316 TABLET in 1 CARTON (54973-4126-3) 16 tablet2024-03-21NoNoCurrent