51316-216 NDC - CVS LEG CRAMPS (CINCHONA OFFICINALIS BARK, ACONITUM NAPELLUS, PSEUDOGNAPHALIUM OBTUSIFOLIUM, LEDUM PALUSTRE TWIG, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, AND VISCUM ALBUM FRUITING TOP)

Drug Information

Product NDC: 51316-216

Proprietary Name: CVS LEG CRAMPS

Non Proprietary Name: cinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting top

Active Ingredient(s):
  • 6 [hp_X]/1 ACONITUM NAPELLUS;
  • 3 [hp_X]/1 CINCHONA OFFICINALIS BARK;
  • 6 [hp_X]/1 LEDUM PALUSTRE TWIG;
  • 6 [hp_X]/1 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE;
  • 3 [hp_X]/1 PSEUDOGNAPHALIUM OBTUSIFOLIUM;
  • 6 [hp_X]/1 TOXICODENDRON PUBESCENS LEAF;
  • 3 [hp_X]/1 VISCUM ALBUM FRUITING TOP


Administration Route(s): ORAL

Dosage Form(s): TABLET, SOLUBLE

Pharmacy Class(es):
  • 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]

Labeler Information

Labeler Name: CVS HEALTH
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:1/25/2022

Package Information

No. Package Code Package Description Billing Unit
151316-216-141 BOTTLE, PLASTIC in 1 CARTON (51316-216-14) / 40 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC51316-216The 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 NAMECVS LEG CRAMPSThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEcinchona officinalis bark, aconitum napellus, pseudognaphalium obtusifolium, ledum palustre twig, magnesium phosphate, dibasic trihydrate, toxicodendron pubescens leaf, and viscum album fruiting topThe 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 DATE1/25/2022This 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 NAMECVS HEALTHName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS; CINCHONA OFFICINALIS BARK; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOPAn 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 STRENGTH6; 3; 6; 6; 3; 6; 3 
ACTIVE INGRED UNIT[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], 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] 

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This page was last updated on: 2/1/2023