NDC 57955-0068 Gallplex

Berberis Vulgaris, Bryonia, Carduus Marianus, Chelidonium Majus, Cholesterinum, Cinchona Officinalis, Colocynthis, Dioscorea Villosa, Lycopodium Clavatum, Natrum Sulphuricum

NDC Product Code 57955-0068

NDC Code: 57955-0068

Proprietary Name: Gallplex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Berberis Vulgaris, Bryonia, Carduus Marianus, Chelidonium Majus, Cholesterinum, Cinchona Officinalis, Colocynthis, Dioscorea Villosa, Lycopodium Clavatum, Natrum Sulphuricum 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.

NDC Code Structure

  • 57955 - King Bio Inc.
    • 57955-0068 - Gallplex

NDC 57955-0068-2

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Gallplex with NDC 57955-0068 is a a human over the counter drug product labeled by King Bio Inc.. The generic name of Gallplex is berberis vulgaris, bryonia, carduus marianus, chelidonium majus, cholesterinum, cinchona officinalis, colocynthis, dioscorea villosa, lycopodium clavatum, natrum sulphuricum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: King Bio 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 Otc 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.

Gallplex 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.

  • BERBERIS VULGARIS ROOT BARK 10 [hp_X]/59mL
  • BRYONIA ALBA ROOT 10 [hp_X]/59mL
  • MILK THISTLE 10 [hp_X]/59mL
  • CHELIDONIUM MAJUS 10 [hp_X]/59mL
  • CHOLESTEROL 10 [hp_X]/59mL
  • CINCHONA OFFICINALIS BARK 10 [hp_X]/59mL
  • CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X]/59mL
  • DIOSCOREA VILLOSA TUBER 10 [hp_X]/59mL
  • LYCOPODIUM CLAVATUM SPORE 10 [hp_X]/59mL
  • SODIUM SULFATE 10 [hp_X]/59mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

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.

Product Labeler Information

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

Labeler Name: King Bio Inc.
Labeler Code: 57955
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: 07-18-2014 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’.

* Please review the disclaimer below.

Gallplex Product Label Images

Gallplex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Drug Facts​
____________________________________________________________________________________________________________________HPUS active ingredients: Berberis vulgaris, Bryonia, Carduus marianus, Chelidonium majus, Cholesterinum, Cinchona officinalis, Colocynthis, Dioscorea villosa, Lycopodium clavatum, Natrum sulphuricum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Indications & Usage

Uses for temporary relief of minor gallbladder symptoms: indigestion, bloating, gas, abdominal discomforts following eating.

Inactive Ingredient

Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, potassium sorbate.

Warnings

  • WarningsStop use and ask your doctor if symptoms persist or worsen.If pregnant or breast-feeding, take only on advice of a healthcare professional.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

  • Directions:Initially, depress pump until primed.Spray one dose directly into mouth.Adults 12 and up: 3 sprays 3 times per day.Use additionally as needed, up to 6 times per day.

Other Safety Information

Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Purpose

  • Uses for temporary relief of minor gallbladder symptoms: indigestionbloatinggasabdominal discomforts following eating

* Please review the disclaimer below.

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