Allergena Zone 9

Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass


Meditrend, Inc. Dba Progena Professional Formulations
Human Otc Drug
NDC 62713-809
Allergena Zone 9 also known as Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass is a human otc drug labeled by 'Meditrend, Inc. Dba Progena Professional Formulations'. National Drug Code (NDC) number for Allergena Zone 9 is 62713-809. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Allergena Zone 9 drug includes Acacia Pollen - 30 [hp_X]/mL Agrostis Gigantea Pollen - 30 [hp_X]/mL Ailanthus Altissima Pollen - 30 [hp_X]/mL Alnus Incana Subsp. Rugosa Pollen - 30 [hp_X]/mL Amaranthus Palmeri Pollen - 30 [hp_X]/mL Amaranthus Retroflexus Pollen - 30 [hp_X]/mL Ambrosia Acanthicarpa Pollen - 30 [hp_X]/mL Ambrosia Psilostachya Pollen - 30 [hp_X]/mL Atriplex Canescens Pollen - 30 [hp_X]/mL Baptisia Tinctoria Root - 3 [hp_X]/mL and more. The currest status of Allergena Zone 9 drug is Active.

Drug Information:

Drug NDC: 62713-809
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: Allergena Zone 9
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Allergena
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Zone 9
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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: Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Meditrend, Inc. Dba Progena Professional Formulations
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:ACACIA POLLEN - 30 [hp_X]/mL
AGROSTIS GIGANTEA POLLEN - 30 [hp_X]/mL
AILANTHUS ALTISSIMA POLLEN - 30 [hp_X]/mL
ALNUS INCANA SUBSP. RUGOSA POLLEN - 30 [hp_X]/mL
AMARANTHUS PALMERI POLLEN - 30 [hp_X]/mL
AMARANTHUS RETROFLEXUS POLLEN - 30 [hp_X]/mL
AMBROSIA ACANTHICARPA POLLEN - 30 [hp_X]/mL
AMBROSIA PSILOSTACHYA POLLEN - 30 [hp_X]/mL
ATRIPLEX CANESCENS POLLEN - 30 [hp_X]/mL
BAPTISIA TINCTORIA ROOT - 3 [hp_X]/mL
BROMUS INERMIS POLLEN - 30 [hp_X]/mL
BROMUS SECALINUS POLLEN - 30 [hp_X]/mL
CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/mL
CYNODON DACTYLON POLLEN - 30 [hp_X]/mL
DACTYLIS GLOMERATA POLLEN - 30 [hp_X]/mL
ECHINACEA, UNSPECIFIED - 3 [hp_X]/mL
EUCALYPTUS GLOBULUS POLLEN - 30 [hp_X]/mL
FENUGREEK LEAF - 3 [hp_X]/mL
FESTUCA PRATENSIS POLLEN - 30 [hp_X]/mL
FRAXINUS VELUTINA POLLEN - 30 [hp_X]/mL
GOLDENSEAL - 3 [hp_X]/mL
JUGLANS NIGRA POLLEN - 30 [hp_X]/mL
JUNIPERUS SCOPULORUM POLLEN - 30 [hp_X]/mL
LIGUSTRUM VULGARE POLLEN - 30 [hp_X]/mL
LIQUIDAMBAR STYRACIFLUA POLLEN - 30 [hp_X]/mL
LOLIUM PERENNE POLLEN - 30 [hp_X]/mL
MORUS ALBA POLLEN - 30 [hp_X]/mL
MYRRH - 3 [hp_X]/mL
NASTURTIUM OFFICINALE - 3 [hp_X]/mL
OLEA EUROPAEA POLLEN - 30 [hp_X]/mL
PHLEUM PRATENSE POLLEN - 30 [hp_X]/mL
PHOENIX DACTYLIFERA POLLEN - 30 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT - 3 [hp_X]/mL
PINUS STROBUS POLLEN - 30 [hp_X]/mL
PLANTAGO LANCEOLATA POLLEN - 30 [hp_X]/mL
PLATANUS OCCIDENTALIS POLLEN - 30 [hp_X]/mL
POA PRATENSIS POLLEN - 30 [hp_X]/mL
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - 30 [hp_X]/mL
PROSOPIS JULIFLORA POLLEN - 30 [hp_X]/mL
QUERCUS AGRIFOLIA POLLEN - 30 [hp_X]/mL
RUMEX CRISPUS POLLEN - 30 [hp_X]/mL
SALIX NIGRA POLLEN - 30 [hp_X]/mL
SALSOLA TRAGUS POLLEN - 30 [hp_X]/mL
SORGHUM HALEPENSE POLLEN - 30 [hp_X]/mL
ULMUS CRASSIFOLIA POLLEN - 30 [hp_X]/mL
ULMUS PUMILA POLLEN - 30 [hp_X]/mL
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: 01 Jan, 1987
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 19 May, 2024
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:Meditrend, Inc. DBA Progena Professional Formulations
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.
NUI:N0000185367
N0000175629
N0000184306
N0000185001
M0017130
M0000728
N0000185006
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:43DDR2YDYZ
HU8V6E7HOA
2A64U81OQ3
605T96G8Y5
1GH3WV23KH
73B14PX5FW
U2AI3H2J5Y
RX18M46K8L
26U0BU8G83
5EF0HWI5WU
766QT72BK6
Q4T1SJ3046
098LKX5NCN
175F461W10
83N78IDA7P
4N9P6CC1DX
7XW7TB10X9
487RI96K8Z
A0WFQ8P6N1
LJT6I6Z8FD
ZW3Z11D0JV
1BV28146ZR
0G82TT8ZFY
Y3FRX92Z0E
5Q246DS5BS
4T81LB52R0
3I9T68187H
JC71GJ1F3L
YH89GMV676
43R41XZ627
65M88RW2EG
2FV55IRB5B
11E6VI8VEG
TX1ER5UV3T
DO87T1U2CI
E03U1K03LK
SCB8J7LS3T
5928LJ1441
6EIJ3D04MR
VOT5MA71M7
V825XJG64G
6M2JIH93ZN
V174354MDI
577VA5B4HP
G82398SD3I
030R993R8E
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.
Pharmacologic Class EPC:Non-Standardized Pollen Allergenic Extract [EPC]
Standardized Pollen Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Pollen [CS]
Allergens [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Allergens [CS]
Cell-mediated Immunity [PE]
Increased Histamine Release [PE]
Increased IgG Production [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
62713-809-0130 mL in 1 BOTTLE, DROPPER (62713-809-01)01 Jan, 1987N/ANo
62713-809-0259 mL in 1 BOTTLE, DROPPER (62713-809-02)01 Jan, 1987N/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:

Purpose: relief from sneezing, runny nose, itchy eyes and sinus congestion.

Product Elements:

Allergena zone 9 echinacea,baptisia tinctoria, hydrastis canadensis, myrrha, nasturtium aquaticum, phytolacca decandra, trigonella foenum-graecum, zone 9 tree, zone 9 weed, zone 9 grass ambrosia psilostachya pollen ambrosia psilostachya pollen salsola tragus pollen salsola tragus pollen cynodon dactylon pollen cynodon dactylon pollen bromus inermis pollen bromus inermis pollen bromus secalinus pollen bromus secalinus pollen sorghum halepense pollen sorghum halepense pollen poa pratensis pollen poa pratensis pollen festuca pratensis pollen festuca pratensis pollen dactylis glomerata pollen dactylis glomerata pollen lolium perenne pollen lolium perenne pollen agrostis gigantea pollen agrostis gigantea pollen phleum pratense pollen phleum pratense pollen water alcohol echinacea, unspecified echinacea, unspecified baptisia tinctoria root baptisia tinctoria root goldenseal goldenseal myrrh myrrh nasturtium officinale nasturtium officinale phytolacca americana root phytolacca americana root fenugreek leaf fenugreek leaf acacia pollen acacia pollen alnus incana subsp. rugosa pollen alnus incana subsp. rugosa pollen fraxinus velutina pollen fraxinus velutina pollen populus deltoides subsp. monilifera pollen populus deltoides subsp. monilifera pollen ulmus crassifolia pollen ulmus crassifolia pollen ulmus pumila pollen ulmus pumila pollen eucalyptus globulus pollen eucalyptus globulus pollen juniperus scopulorum pollen juniperus scopulorum pollen ligustrum vulgare pollen ligustrum vulgare pollen prosopis juliflora pollen prosopis juliflora pollen morus alba pollen morus alba pollen quercus agrifolia pollen quercus agrifolia pollen olea europaea pollen olea europaea pollen phoenix dactylifera pollen phoenix dactylifera pollen pinus strobus pollen pinus strobus pollen liquidambar styraciflua pollen liquidambar styraciflua pollen platanus occidentalis pollen platanus occidentalis pollen ailanthus altissima pollen ailanthus altissima pollen juglans nigra pollen juglans nigra pollen salix nigra pollen salix nigra pollen atriplex canescens pollen atriplex canescens pollen amaranthus palmeri pollen amaranthus palmeri pollen rumex crispus pollen rumex crispus pollen chenopodium album pollen chenopodium album pollen amaranthus retroflexus pollen amaranthus retroflexus pollen plantago lanceolata pollen plantago lanceolata pollen ambrosia acanthicarpa pollen ambrosia acanthicarpa pollen

Indications and Usage:

Use: this product is a homeopathic dilution formulated to support the body's immunity for the temporary relief of allergies.

Warnings:

Warnings: use only as directed. stop use and ask a doctor if symptoms worsen or do not improve after 5 days. if pregnant or breast-feeding , consult a health professional before use.

Dosage and Administration:

Directions: •shake well before use.• adults (12 and older) take 10-15 drops under the tongue three times daily.• children (11 and younger) take 6 drops under the tongue three times daily or as directed by your health care professional.• consult a physician for use in children under 12 years of age.

Package Label Principal Display Panel:

*proprietary ingredients: zone 9 trees, weeds and grasses contain up to 40 allergens specific to zone 9 region. for a complete list of allergens visit www.allergena.com manufactured for progena professional formulations 4820 eubank blvd. ne, abq, nm 87111, www.progena.com image of label


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.