54973-3382 NDC - 4 KIDS COMPLETE ALLERGY DAYTIME (SODIUM CHLORIDE, ACONITUM NAPELLUS, LUFFA OPERCULATA FRUIT, EUPHRASIA STRICTA,GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE,ONION,ANEMONE PULSATILLA AND SCHOENNOCAULON OFFICINALE SEED)

Drug Information

Product NDC: 54973-3382

Proprietary Name: 4 Kids Complete Allergy Daytime

Non Proprietary Name: Sodium Chloride, Aconitum Napellus, Luffa Operculata Fruit, Euphrasia Stricta,Galphimia Glauca Flowering Top, Histamine Dihydrochloride,Onion,Anemone Pulsatilla and Schoennocaulon Officinale Seed

Active Ingredient(s):
  • 6 [hp_X]/mL ACONITUM NAPELLUS;
  • 6 [hp_X]/mL ANEMONE PULSATILLA;
  • 6 [hp_X]/mL EUPHRASIA STRICTA;
  • 12 [hp_X]/mL GALPHIMIA GLAUCA FLOWERING TOP;
  • 12 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE;
  • 12 [hp_X]/mL LUFFA OPERCULATA FRUIT;
  • 6 [hp_X]/mL ONION;
  • 6 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED;
  • 6 [hp_X]/mL SODIUM CHLORIDE


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Dietary Proteins [CS];
  • Increased Histamine Release [PE];
  • Non-Standardized Food Allergenic Extract [EPC];
  • Vegetable Proteins [CS]

Labeler Information

Labeler Name: Hyland's Inc.
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
154973-3382-11 BOTTLE, PLASTIC in 1 CARTON (54973-3382-1) > 118 mL in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC54973-3382The 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 Complete Allergy DaytimeThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESodium Chloride, Aconitum Napellus, Luffa Operculata Fruit, Euphrasia Stricta,Galphimia Glauca Flowering Top, Histamine Dihydrochloride,Onion,Anemone Pulsatilla and Schoennocaulon Officinale SeedThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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's Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACONITUM NAPELLUS; ANEMONE PULSATILLA; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; ONION; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH6; 6; 6; 12; 12; 12; 6; 6; 6 
ACTIVE INGRED UNIT[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS] 

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This page was last updated on: 2/14/2022