54973-3383 NDC - 4 KIDS LEG PAIN RELIEF (TRIBASIC CALCIUM PHOSPHATE, ARNICA MONTANA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, COPPER, EUPATORIUM PERFOLIATUM FLOWERING TOP, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, PHOSPHORUS, GUAIACUM OFFICINALE RESIN AND PHOSPHORIC ACID)

Drug Information

Product NDC: 54973-3383

Proprietary Name: 4 Kids Leg Pain Relief

Non Proprietary Name: Tribasic Calcium Phosphate, Arnica Montana, Oyster Shell Calcium Carbonate, Crude, Copper, Eupatorium Perfoliatum Flowering Top, Magnesium Phosphate, Dibasic Trihydrate, Phosphorus, Guaiacum Officinale Resin and Phosphoric Acid

Active Ingredient(s):
  • 30 [hp_X]/1 ARNICA MONTANA;
  • 12 [hp_X]/1 COPPER;
  • 30 [hp_X]/1 EUPATORIUM PERFOLIATUM FLOWERING TOP;
  • 12 [hp_X]/1 GUAIACUM OFFICINALE RESIN;
  • 12 [hp_X]/1 MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE;
  • 12 [hp_X]/1 OYSTER SHELL CALCIUM CARBONATE, CRUDE;
  • 12 [hp_X]/1 PHOSPHORIC ACID;
  • 12 [hp_X]/1 PHOSPHORUS;
  • 12 [hp_X]/1 TRIBASIC CALCIUM PHOSPHATE


Administration Route(s): ORAL

Dosage Form(s): TABLET

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

Labeler Name: Hyland's
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:11/1/2018

Package Information

No. Package Code Package Description Billing Unit
154973-3383-11 BOTTLE, PLASTIC in 1 CARTON (54973-3383-1) > 50 TABLET in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC54973-3383The 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 NAME4 Kids Leg Pain ReliefThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMETribasic Calcium Phosphate, Arnica Montana, Oyster Shell Calcium Carbonate, Crude, Copper, Eupatorium Perfoliatum Flowering Top, Magnesium Phosphate, Dibasic Trihydrate, Phosphorus, Guaiacum Officinale Resin and Phosphoric AcidThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe 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 DATE11/1/2018This 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 NAMEARNICA MONTANA; COPPER; EUPATORIUM PERFOLIATUM FLOWERING TOP; GUAIACUM OFFICINALE RESIN; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORIC ACID; PHOSPHORUS; TRIBASIC CALCIUM PHOSPHATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH30; 12; 30; 12; 12; 12; 12; 12; 12 
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 
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: 2/14/2022