FDA.reportPublic FDA data

LEG CRAMPS

Product NDC
54973-3114
Requested package NDC
54973-3114-7
11-digit product format
549733114
Labeler code
54973
Product ID
54973-3114_ec71c58d-a5f0-d6a5-e053-2995a90a2ab2
Type
HUMAN OTC DRUG
Nonproprietary name
cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top
Dosage form
TABLET, SOLUBLE
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1995-12-04
Substance
CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP
Active strength
3; 6; 3; 6; 6; 6; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
LEG CRAMPS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CINCHONA OFFICINALIS BARK3 [hp_X]/1
ACONITUM NAPELLUS6 [hp_X]/1
PSEUDOGNAPHALIUM OBTUSIFOLIUM3 [hp_X]/1
LEDUM PALUSTRE TWIG6 [hp_X]/1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]/1
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/1
VISCUM ALBUM FRUITING TOP3 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S003A158SBInternal UNII lookup
U0NQ8555JDInternal UNII lookup
36XQ854NWWInternal UNII lookup
877L01IZ0PInternal UNII lookup
HF539G9L3QInternal UNII lookup
6IO182RP7AInternal UNII lookup
BK9092J5MPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77630c9b-880d-4de1-ae25-5a01050727f7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3114-1LEG CRAMPS4 in 1 POUCHTABLET, SOLUBLE412
54973-3114-2LEG CRAMPS40 in 1 BOTTLE, PLASTICTABLET, SOLUBLE4012
54973-3114-2LEG CRAMPS1 in 1 CARTONTABLET, SOLUBLE112
54973-3114-3LEG CRAMPS3 in 1 CARTONTABLET, SOLUBLE312
54973-3114-4LEG CRAMPS100 in 1 BOTTLE, PLASTICTABLET, SOLUBLE10012
54973-3114-4LEG CRAMPS1 in 1 CARTONTABLET, SOLUBLE112
54973-3114-5LEG CRAMPS1 in 1 CARTONTABLET, SOLUBLE112
54973-3114-5LEG CRAMPS16 in 1 BOTTLE, PLASTICTABLET, SOLUBLE1612
54973-3114-7LEG CRAMPS1 in 1 CARTONTABLET, SOLUBLE112
54973-3114-7LEG CRAMPS16 in 1 BOTTLE, PLASTICTABLET, SOLUBLE1612

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3114-2EA - Each54973-3114a21d52cd-633a-42ba-a64c-749c477433cb12019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JDLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
CINCHONA OFFICINALIS BARKACTIVE INGREDIENTS003A158SBLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0PLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3QLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE INGREDIENT36XQ854NWWLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ALEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
VISCUM ALBUM FRUITING TOPACTIVE INGREDIENTBK9092J5MPLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JDLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
CINCHONA OFFICINALIS BARKACTIVE MOIETYS003A158SBLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0PLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838LEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE MOIETY36XQ854NWWLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ALEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
VISCUM ALBUM FRUITING TOPACTIVE MOIETYBK9092J5MPLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GLEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3114LEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP) TABLET, SOLUBLE [HYLAND'S INC.]12Current NDC, Legacy NDC, 10 package rows20221103_77630c9b-880d-4de1-ae25-5a01050727f7.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
LEG CRAMPSCINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOPHyland's Inc.77630c9b-880d-4de1-ae25-5a01050727f72022-11-02WarningsExact identifier
ndc (package): 54973-3114-7
ndc (product): 54973-3114
ndc11 (package): 54973311407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3114-7549733114071 BOTTLE, PLASTIC in 1 CARTON (54973-3114-7) / 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC1995-12-040000-00-00NoNoCurrent