NDC 55714-2242 Prostate

Thyroidinum, Baryta Carb., Berber. Vulg., Bryonia, Calc. Carb., Cinchona, Conium, Digitalis, Ferrum Picricum, Hydrastis, Iodium, Lycopodium, Nux Vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja Occ.,trifolium Pratense, Echinacea, Lappa, Solidago.

NDC Product Code 55714-2242

NDC Code: 55714-2242

Proprietary Name: Prostate 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: Thyroidinum, Baryta Carb., Berber. Vulg., Bryonia, Calc. Carb., Cinchona, Conium, Digitalis, Ferrum Picricum, Hydrastis, Iodium, Lycopodium, Nux Vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja Occ.,trifolium Pratense, Echinacea, Lappa, Solidago. 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-2242 - Prostate

NDC 55714-2242-0

Package Description: .5 mL in 1 BOTTLE, GLASS

NDC 55714-2242-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-2242-2

Package Description: 59.14 mL in 1 BOTTLE, GLASS

NDC Product Information

Prostate with NDC 55714-2242 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Prostate is thyroidinum, baryta carb., berber. vulg., bryonia, calc. carb., cinchona, conium, digitalis, ferrum picricum, hydrastis, iodium, lycopodium, nux vom., pareira, pulsatilla, sabal, selenium, staphysag., thuja occ.,trifolium pratense, echinacea, lappa, solidago.. 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 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.

Prostate 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.

  • THYROID, UNSPECIFIED 15 [hp_X]/mL
  • BARIUM CARBONATE 10 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 10 [hp_X]/mL
  • BRYONIA ALBA ROOT 10 [hp_X]/mL
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 10 [hp_X]/mL
  • CONIUM MACULATUM FLOWERING TOP 10 [hp_X]/mL
  • DIGITALIS 10 [hp_X]/mL
  • FERRIC PICRATE 10 [hp_X]/mL
  • GOLDENSEAL 10 [hp_X]/mL
  • IODINE 10 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 10 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 10 [hp_X]/mL
  • CHONDRODENDRON TOMENTOSUM ROOT 10 [hp_X]/mL
  • PULSATILLA VULGARIS 10 [hp_X]/mL
  • SAW PALMETTO 10 [hp_X]/mL
  • SELENIUM 10 [hp_X]/mL
  • DELPHINIUM STAPHISAGRIA SEED 10 [hp_X]/mL
  • THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X]/mL
  • TRIFOLIUM PRATENSE FLOWER 10 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • ARCTIUM LAPPA ROOT 3 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]/mL

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.

  • ALCOHOL (UNII: 3K9958V90M)

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: 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: 03-01-2011 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’.

* Please review the disclaimer below.

Prostate Product Label Images

Prostate 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

Indications & Usage Section

Prostate    Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Dosage & Administration Section

Directions: ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Thyroidinum 15x, Baryta carb. 10x, Berber. vulg. 10x, Bryonia 10x, Calc. carb. 10x, Cinchona 10x,Conium 10x, Digitalis 10x, Ferrum picricum 10x, Hydrastis 10x, Iodium 10x, Lycopodium 10x, Nux vom. 10x, Pareira 10x, Pulsatilla 10x, Sabal 10x, Selenium 10x, Staphysag. 10x, Thuja occ. 10x, Trifolium pratense 10x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.

Otc - Purpose Section

Formulated for associated symptoms such as enlargement, discomfort, frequent, incomplete or difficult urination and sexual dysfunction.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Questions Section

Www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

Previous Code
55714-2241
Next Code
55714-2243