Baby Nighttime Mucus Plus Cold Relief Liquid
NDC 54973-3371
13 active ingredients · Liquid (oral)
Product Information
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) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Hyland's Inc.. This medication is typically used as a allergens [cs]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 54973-3371 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
54973-3371
Proprietary Name:
Baby Nighttime Mucus Plus Cold Relief
Non-Proprietary Name: [1]
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
Substance Name: [2]
Calcium Sulfide; Phosphorus; Anemone Pulsatilla; Silicon Dioxide; Goldenseal; Onion; Bryonia Alba Root; Euphrasia Stricta; Matricaria Chamomilla; Arabica Coffee Bean; Sodium Chloride; Rumex Crispus Root; Sulfur
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Liquid
- A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
54973
Product Label ID:
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Marketing Timeline
Start Marketing Date: [9]
11-01-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 54973-3371?
The NDC code 54973-3371 is assigned by the FDA to the product Baby Nighttime Mucus Plus Cold Relief. It is commonly known by its generic 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. This pharmaceutical product is labeled by Hyland's Inc. and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 54973-3371-1, 54973-3371-2, 54973-3371-3. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
• Measure only with the dosing syringe provided
• Do not use dosing syringe with other products
• On dosing syringe, mL = milliliter, tsp = teaspoon
Measure only with the dosing syringe providedDo not use dosing syringe with other productsOn dosing syringe, mL = milliliter, tsp = teaspoonChildren under6 months of ageconsult a licensed health care professionalbefore using this productChildren 6 months tounder 1 year of age2.5 mL or ½ tsp at bedtime and every6 hours during the night or as necessaryChildren 1 to 3years of age5 mL or 1 tsp at bedtime and every 4 hoursduring the night or as necessary
What are Active Ingredients of this product?
An 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.
- CALCIUM SULFIDE 12 [hp_X]/mL - RN given refers to parent cpd; see also record for lime sulfur (calcium polysulfide)
- PHOSPHORUS 30 [hp_X]/mL - A non-metal element that has the atomic symbol P, atomic number 15, and atomic weight 31. It is an essential element that takes part in a broad variety of biochemical reactions.
- ANEMONE PULSATILLA 6 [hp_X]/mL
- SILICON DIOXIDE 12 [hp_X]/mL - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.
- GOLDENSEAL 6 [hp_X]/mL
- ONION 6 [hp_X]/mL - Herbaceous biennial plants and their edible bulbs, belonging to the Allium genus.
- BRYONIA ALBA ROOT 6 [hp_X]/mL
- EUPHRASIA STRICTA 6 [hp_X]/mL
- MATRICARIA CHAMOMILLA 3 [hp_X]/mL
- ARABICA COFFEE BEAN 3 [hp_X]/mL
- SODIUM CHLORIDE 6 [hp_X]/mL - A ubiquitous sodium salt that is commonly used to season food.
- RUMEX CRISPUS ROOT 6 [hp_X]/mL
- SULFUR 12 [hp_X]/mL - An element that is a member of the chalcogen family. It has an atomic symbol S, atomic number 16, and atomic weight [32.059; 32.076]. It is found in the amino acids cysteine and methionine.
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
- Allergens - [CS]
- Cell-mediated Immunity - [PE] (Physiologic Effect)
- Dietary Proteins - [CS]
- Increased Histamine Release - [PE] (Physiologic Effect)
- Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Plant Proteins - [CS]
- Seed Storage Proteins - [CS]
- Vegetable Proteins - [CS]
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An 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.
What kind of product is this? Indicates 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
