54973-3324 NDC - BABY NIGHTTIME ORAL PAIN RELIEF (ARNICA MONTANA, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA CHAMOMILLA, SILICON DIOXIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, FERROSOFERRIC PHOSPHATE, ARABICA COFFEE BEAN AND OYSTER SHELL CALCIUM CARBONATE, CRUDE)

Drug Information

  • Product NDC: 54973-3324
  • Proprietary Name: Baby Nighttime Oral Pain Relief
  • Non Proprietary Name: Arnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, Crude
  • Active Ingredient(s): 6 [hp_X]/g ARABICA COFFEE BEAN; 30 [hp_X]/g ARNICA MONTANA; 12 [hp_X]/g FERROSOFERRIC PHOSPHATE; 12 [hp_X]/g MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; 12 [hp_X]/g MATRICARIA CHAMOMILLA; 12 [hp_X]/g OYSTER SHELL CALCIUM CARBONATE, CRUDE; 12 [hp_X]/g SILICON DIOXIDE; 12 [hp_X]/g TRIBASIC CALCIUM PHOSPHATE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Allergens [CS]; Calculi Dissolution Agent [EPC]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Field Name Field Value
Labeler Name: Hyland' Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/17/2017

Package Information

No. Package Code Package Description Billing Unit
154973-3324-11 BOTTLE, PLASTIC in 1 CARTON (54973-3324-1) / 1 g in 1 BOTTLE, PLASTIC
254973-3324-46 g in 1 PACKET (54973-3324-4)

NDC Record

Field Name Field Value Definition
PRODUCT NDC54973-3324The 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 NAMEBaby Nighttime Oral 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 NAMEArnica Montana, Tribasic Calcium Phosphate, Matricaria Chamomilla, Silicon Dioxide, Magnesium Phosphate, Dibasic Trihydrate, Ferrosoferric Phosphate, Arabica Coffee Bean and Oyster Shell Calcium Carbonate, CrudeThe 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 DATE8/17/2017This 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' Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEARABICA COFFEE BEAN; ARNICA MONTANA; FERROSOFERRIC PHOSPHATE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATEAn 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; 30; 12; 12; 12; 12; 12; 12 
ACTIVE INGRED UNIT[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g 
PHARM CLASSESAllergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

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This page was last updated on: 4/4/2025

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