54973-3093 NDC - LEG CRAMPS PM (OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR)

Drug Information

  • Product NDC: 54973-3093
  • Proprietary Name: Leg Cramps PM
  • Non Proprietary Name: oyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfur
  • Active Ingredient(s): 12 [hp_X]/1 CAUSTICUM; 3 [hp_X]/1 CINCHONA OFFICINALIS BARK; 12 [hp_X]/1 COPPER; 12 [hp_X]/1 LYCOPODIUM CLAVATUM SPORE; 6 [hp_X]/1 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; 6 [hp_X]/1 MATRICARIA RECUTITA; 12 [hp_X]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE; 12 [hp_X]/1 SILICON DIOXIDE; 6 [hp_X]/1 SULFUR; 6 [hp_X]/1 TOXICODENDRON PUBESCENS LEAF
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, SOLUBLE
  • Pharmacy Class(es): Calculi Dissolution Agent [EPC]; Copper [CS]; Copper-containing Intrauterine Device [EPC]; Decreased Embryonic Implantation [PE]; Decreased Sperm Motility [PE]; Increased Large Intestinal Motility [PE]; Inhibit Ovum Fertilization [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]

Labeler Information

Field Name Field Value
Labeler Name: Hyland's Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/1/2010

Package Information

No. Package Code Package Description Billing Unit
154973-3093-150 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC (54973-3093-1)EA
254973-3093-21 BOTTLE in 1 CARTON (54973-3093-2) / 30 TABLET, SOLUBLE in 1 BOTTLE
354973-3093-64 TABLET, SOLUBLE in 1 POUCH (54973-3093-6)
454973-3093-71 BOTTLE, PLASTIC in 1 CARTON (54973-3093-7) / 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC
554973-3093-81 BOTTLE, PLASTIC in 1 CARTON (54973-3093-8) / 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC54973-3093The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMELeg Cramps PMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEoyster shell calcium carbonate, crude, causticum, matricaria recutita, cinchona officinalis bark, copper, lycopodium clavatum spore, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, silicon dioxide, and sulfurThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, SOLUBLEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEHyland's Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECAUSTICUM; CINCHONA OFFICINALIS BARK; COPPER; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA RECUTITA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; SULFUR; TOXICODENDRON PUBESCENS LEAFAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH12; 3; 12; 12; 6; 6; 12; 12; 6; 6 
ACTIVE INGRED UNIT[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 
PHARM CLASSESCalculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [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] 

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This page was last updated on: 11/21/2025

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