54973-3371 NDC - BABY NIGHTTIME MUCUS PLUS COLD RELIEF (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA)

Drug Information

  • Product NDC: 54973-3371
  • Proprietary Name: Baby Nighttime Mucus Plus Cold Relief
  • Non Proprietary Name: CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA and MATRICARIA CHAMOMILLA
  • Active Ingredient(s): 6 [hp_X]/mL ANEMONE PULSATILLA; 3 [hp_X]/mL ARABICA COFFEE BEAN; 6 [hp_X]/mL BRYONIA ALBA ROOT; 12 [hp_X]/mL CALCIUM SULFIDE; 6 [hp_X]/mL EUPHRASIA STRICTA; 6 [hp_X]/mL GOLDENSEAL; 3 [hp_X]/mL MATRICARIA CHAMOMILLA; 6 [hp_X]/mL ONION; 30 [hp_X]/mL PHOSPHORUS; 6 [hp_X]/mL RUMEX CRISPUS ROOT; 12 [hp_X]/mL SILICON DIOXIDE; 6 [hp_X]/mL SODIUM CHLORIDE; 12 [hp_X]/mL SULFUR
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Vegetable Proteins [CS]

Labeler Information

Field Name Field Value
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
154973-3371-11 BOTTLE, PLASTIC in 1 CARTON (54973-3371-1) / 148 mL in 1 BOTTLE, PLASTIC
254973-3371-21 BOTTLE, PLASTIC in 1 CARTON (54973-3371-2) / 118 mL in 1 BOTTLE, PLASTIC
354973-3371-32.5 mL in 1 PACKET (54973-3371-3)

NDC Record

Field Name Field Value Definition
PRODUCT NDC54973-3371The 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 Mucus Plus Cold 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 NAMECALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA and MATRICARIA CHAMOMILLAThe 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 NAMEANEMONE PULSATILLA; ARABICA COFFEE BEAN; BRYONIA ALBA ROOT; CALCIUM SULFIDE; EUPHRASIA STRICTA; GOLDENSEAL; MATRICARIA CHAMOMILLA; ONION; PHOSPHORUS; RUMEX CRISPUS ROOT; SILICON DIOXIDE; SODIUM CHLORIDE; SULFURAn 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; 12; 6; 6; 3; 6; 30; 6; 12; 6; 12 
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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS] 

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This page was last updated on: 4/25/2025

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