54973-3162 NDC - RESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC)

Drug Information

Product NDC: 54973-3162

Proprietary Name: Restful Legs

Non Proprietary Name: arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc

Active Ingredient(s):
  • 12 [hp_X]/1 ARSENIC TRIOXIDE;
  • 6 [hp_X]/1 LYCOPODIUM CLAVATUM SPORE;
  • 6 [hp_X]/1 PULSATILLA VULGARIS;
  • 6 [hp_X]/1 TOXICODENDRON PUBESCENS LEAF;
  • 6 [hp_X]/1 SULFUR;
  • 12 [hp_X]/1 ZINC


Administration Route(s): ORAL

Dosage Form(s): TABLET, SOLUBLE

Labeler Information

Labeler Name: Hyland's
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:7/17/2006

Package Information

No. Package Code Package Description Billing Unit
154973-3162-11 BOTTLE, PLASTIC in 1 CARTON (54973-3162-1) > 50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC
254973-3162-24 TABLET, SOLUBLE in 1 PACKET (54973-3162-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC54973-3162The 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 NAMERestful LegsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEarsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zincThe 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 DATE7/17/2006This 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'sName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SULFUR; ZINCThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH12; 6; 6; 6; 6; 12 
ACTIVE INGRED UNIT[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 

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This page was last updated on: 11/18/2019