Proaller

Ailanthus Altissima Whole, Okoubaka Aubrevillei Bark, Euphrasia Stricta, Gratiola Officinalis, Juglans Regia Whole, Smilax Regelii Root, And Taraxacum Officinale Whole


Pekana Naturheilmittel
Human Otc Drug
NDC 59469-116
Proaller also known as Ailanthus Altissima Whole, Okoubaka Aubrevillei Bark, Euphrasia Stricta, Gratiola Officinalis, Juglans Regia Whole, Smilax Regelii Root, And Taraxacum Officinale Whole is a human otc drug labeled by 'Pekana Naturheilmittel'. National Drug Code (NDC) number for Proaller is 59469-116. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Proaller drug includes Ailanthus Altissima Whole - 4 [hp_X]/50mL Euphrasia Stricta - 3 [hp_X]/50mL Gratiola Officinalis Whole - 4 [hp_X]/50mL Juglans Regia Whole - 6 [hp_X]/50mL Okoubaka Aubrevillei Bark - 3 [hp_X]/50mL Smilax Ornata Root - 8 [hp_X]/50mL Taraxacum Officinale Whole - 12 [hp_X]/50mL . The currest status of Proaller drug is Active.

Drug Information:

Drug NDC: 59469-116
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Proaller
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Ailanthus Altissima Whole, Okoubaka Aubrevillei Bark, Euphrasia Stricta, Gratiola Officinalis, Juglans Regia Whole, Smilax Regelii Root, And Taraxacum Officinale Whole
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Pekana Naturheilmittel
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:AILANTHUS ALTISSIMA WHOLE - 4 [hp_X]/50mL
EUPHRASIA STRICTA - 3 [hp_X]/50mL
GRATIOLA OFFICINALIS WHOLE - 4 [hp_X]/50mL
JUGLANS REGIA WHOLE - 6 [hp_X]/50mL
OKOUBAKA AUBREVILLEI BARK - 3 [hp_X]/50mL
SMILAX ORNATA ROOT - 8 [hp_X]/50mL
TARAXACUM OFFICINALE WHOLE - 12 [hp_X]/50mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 11 Dec, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:PEKANA Naturheilmittel
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:5G78C6GB5E
C9642I91WL
BDD9991A36
87EJ76IO83
MK2074187Z
2H1576D5WG
7C42E2D7B0
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
59469-116-101 BOTTLE, GLASS in 1 BOX (59469-116-10) / 50 mL in 1 BOTTLE, GLASS11 Dec, 2008N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

For temporary relief of allergies and hay fever symptoms. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.

Product Elements:

Proaller ailanthus altissima whole, okoubaka aubrevillei bark, euphrasia stricta, gratiola officinalis, juglans regia whole, smilax regelii root, and taraxacum officinale whole ailanthus altissima whole ailanthus altissima whole okoubaka aubrevillei bark okoubaka aubrevillei bark euphrasia stricta euphrasia stricta gratiola officinalis whole gratiola officinalis whole juglans regia whole juglans regia whole smilax ornata root smilax ornata root taraxacum officinale whole taraxacum officinale whole water alcohol

Indications and Usage:

Indications for temporary relief of allergies and hay fever symptoms. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.

Warnings:

Warning if symptoms persist, contact a licensed practitioner. if you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. if you are pregnant or nursing a baby, seek the advice of a health care professional before use. keep out of the reach of children. protect from light and heat. tamper evident do not use this product if tamper evident strip is broken or removed from base of cap.

Dosage and Administration:

Dosage unless otherwise prescribed, adults take 15-20 drops, 3 times per day. for pediatric dosages, consult your practitioner.

Package Label Principal Display Panel:

Principal display panel - 50 ml bottle box proaller ™ oral drops homeopathic medicine for temporary relief of allergies and hay fever symptoms 1.7 fl oz (50 ml) pekana ® principal display panel - 50 ml bottle box

Further Questions:

To report adverse events, contact bioresource at 321b blodgett street, cotati, ca 94931


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.