FDA.reportPublic FDA data

Hylands Leg Cramps With Arnica

Product NDC
54973-4126
Requested package NDC
54973-4126-3
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

Additional Listing Data#

Finished product
Yes
Brand name base
Hylands Leg Cramps With Arnica
Listing expiration
2027-12-31

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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-e063-6394a90a7fc92026-08-04WarningsExact identifier
ndc (package): 54973-4126-3
ndc (product): 54973-4126
ndc11 (package): 54973412603

Packages#

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