NDC 58264-0209 N-11
Cinchona Officinalis Bark, Phosphoric Acid, Anemone Pulsatilla, Phosphorus, Picric Aci...

Product Information

What is NDC 58264-0209?

The NDC code 58264-0209 is assigned by the FDA to the product N-11 which is a human over the counter drug product labeled by Dna Labs, Inc.. The generic name of N-11 is cinchona officinalis bark, phosphoric acid, anemone pulsatilla, phosphorus, picric acid, dibasic potassium phosphate, bos taurus pituitary gland, posterior, bos taurus adrenal gland, sus scrofa testicle, and bos taurus prostate gland. The product's dosage form is solution and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 58264-0209-1 29.57 ml in 1 bottle, glass . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code58264-0209
Proprietary Name 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.
N-11
Non-Proprietary Name 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.
Cinchona Officinalis Bark, Phosphoric Acid, Anemone Pulsatilla, Phosphorus, Picric Acid, Dibasic Potassium Phosphate, Bos Taurus Pituitary Gland, Posterior, Bos Taurus Adrenal Gland, Sus Scrofa Testicle, And Bos Taurus Prostate Gland
Product Type 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.
Human Otc Drug
Dosage FormSolution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Sublingual - Administration beneath the tongue.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Dna Labs, Inc.
Labeler Code58264
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-01-1990
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for N-11?


Product Packages

NDC Code 58264-0209-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

Product Details

What are N-11 Active Ingredients?

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.

N-11 Active Ingredients UNII Codes

N-11 Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

N-11 Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



NDC 58264-0209-1

  • Use only if cap seal is unbroken.
  • To be used according to standard homeopathic indications.


Otc - Purpose



Exhaustion, mood swings, and fatigue in men.


Active



Cinchona officinalis 6x, Acidum phosphoricum 6x, Pulsatilla 6x, Phosphorus 6x, Acidum picricum 6x, Kalium phosphoricum 6x, Glandulars: Pituitary, Adrenal, Orchic, Prostate 6/12/30/60/200x


Inactive



20% alcohol in purified water.


Suggested Dosage



One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.


Storage And Handling



SHAKE WELL


Otc - Pregnancy Or Breast Feeding



  • If pregnant or breastfeeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children



  • Keep this and all medication out of the reach of children.

Principal Display Panel - 1 Fl. Oz. Bottle Label



DYNAMIC
NUTRITIONAL

ASSOCIATES, INC.

N-11
ANDRO PLEX

HOMEOPATHIC ENDOCRINE

1 FL. OZ.


* Please review the disclaimer below.