NDC 55714-4400 Drainer

Drainer with NDC 55714-4400 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Drainer is benzoic acidum, berberis vulg., bryonia, cantharis,carduus benedictus, ceanothus, chelidonium majus, chionanthus virginica, cinchona, dioscorea, dolichos, iris versicolor, juniperus com., nux vom., ptelea, taraxacum, uricum acidum, carduus mar., cynara scolymus, solidago, taraxacum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

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.

Product Type: Human Prescription Drug 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.

Drainer Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

• BENZOIC ACID 15 [hp_X]/mL
• BERBERIS VULGARIS ROOT BARK 15 [hp_X]/mL
• BRYONIA ALBA ROOT 15 [hp_X]/mL
• LYTTA VESICATORIA 15 [hp_X]/mL
• CNICUS BENEDICTUS 15 [hp_X]/mL
• CEANOTHUS AMERICANUS LEAF 15 [hp_X]/mL
• CHELIDONIUM MAJUS 15 [hp_X]/mL
• CHIONANTHUS VIRGINICUS BARK 15 [hp_X]/mL
• CINCHONA OFFICINALIS BARK 15 [hp_X]/mL
• DIOSCOREA VILLOSA TUBER 15 [hp_X]/mL
• MUCUNA PRURIENS FRUIT TRICHOME 15 [hp_X]/mL
• IRIS VERSICOLOR ROOT 15 [hp_X]/mL
• JUNIPER 15 [hp_X]/mL
• STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL
• PTELEA TRIFOLIATA BARK 15 [hp_X]/mL
• TARAXACUM OFFICINALE 15 [hp_X]/mL
• URIC ACID 15 [hp_X]/mL
• SILYBUM MARIANUM SEED 3 [hp_X]/mL
• CYNARA SCOLYMUS LEAF 3 [hp_X]/mL
• SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]/mL
• TARAXACUM OFFICINALE 3 [hp_X]/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

• Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

• Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
• Increased Histamine Release - [PE] (Physiologic Effect)
• Cell-mediated Immunity - [PE] (Physiologic Effect)
• Increased IgG Production - [PE] (Physiologic Effect)
• Allergens - [CS]
• Plant Proteins - [CS]
• Seed Storage Proteins - [CS]
• Ammonium Ion Binding Activity - [MoA] (Mechanism of Action)
• Nitrogen Binding Agent - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Newton Laboratories, Inc.
Labeler Code: 55714
Marketing Category: UNAPPROVED HOMEOPATHIC - 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.
Start Marketing Date: 06-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2018 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.
Exclude Flag: E 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. Values = ‘Y’ or ‘N’.

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