Allergena Zone 8

Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 8 Tree, Zone 8 Weed, Zone 8 Grass


Meditrend, Inc. Dba Progena Professional Formulations
Human Otc Drug
NDC 62713-823
Allergena Zone 8 also known as Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 8 Tree, Zone 8 Weed, Zone 8 Grass is a human otc drug labeled by 'Meditrend, Inc. Dba Progena Professional Formulations'. National Drug Code (NDC) number for Allergena Zone 8 is 62713-823. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Allergena Zone 8 drug includes Acer Rubrum Pollen - 30 [hp_X]/mL Acer Saccharum Pollen - 30 [hp_X]/mL Agrostis Gigantea Pollen - 30 [hp_X]/mL Ailanthus Altissima Pollen - 30 [hp_X]/mL Alnus Rubra Pollen - 30 [hp_X]/mL Amaranthus Retroflexus Pollen - 30 [hp_X]/mL Amaranthus Spinosus Pollen - 30 [hp_X]/mL Amaranthus Tuberculatus Pollen - 30 [hp_X]/mL Ambrosia Acanthicarpa Pollen - 30 [hp_X]/mL Anthoxanthum Odoratum Pollen - 30 [hp_X]/mL and more. The currest status of Allergena Zone 8 drug is Active.

Drug Information:

Drug NDC: 62713-823
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 8
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 8
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 8 Tree, Zone 8 Weed, Zone 8 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:ACER RUBRUM POLLEN - 30 [hp_X]/mL
ACER SACCHARUM POLLEN - 30 [hp_X]/mL
AGROSTIS GIGANTEA POLLEN - 30 [hp_X]/mL
AILANTHUS ALTISSIMA POLLEN - 30 [hp_X]/mL
ALNUS RUBRA POLLEN - 30 [hp_X]/mL
AMARANTHUS RETROFLEXUS POLLEN - 30 [hp_X]/mL
AMARANTHUS SPINOSUS POLLEN - 30 [hp_X]/mL
AMARANTHUS TUBERCULATUS POLLEN - 30 [hp_X]/mL
AMBROSIA ACANTHICARPA POLLEN - 30 [hp_X]/mL
ANTHOXANTHUM ODORATUM POLLEN - 30 [hp_X]/mL
ARTEMISIA ABSINTHIUM POLLEN - 30 [hp_X]/mL
ARTEMISIA LUDOVICIANA POLLEN - 30 [hp_X]/mL
ARTEMISIA TRIDENTATA POLLEN - 30 [hp_X]/mL
ARTEMISIA VULGARIS POLLEN - 30 [hp_X]/mL
ATRIPLEX CANESCENS POLLEN - 30 [hp_X]/mL
ATRIPLEX CONFERTIFOLIA POLLEN - 30 [hp_X]/mL
AVENA SATIVA POLLEN - 30 [hp_X]/mL
BAPTISIA TINCTORIA ROOT - 3 [hp_X]/mL
BASSIA SCOPARIA POLLEN - 30 [hp_X]/mL
BETULA NIGRA POLLEN - 30 [hp_X]/mL
BROMUS INERMIS POLLEN - 30 [hp_X]/mL
CARYA ALBA POLLEN - 30 [hp_X]/mL
CELTIS OCCIDENTALIS POLLEN - 30 [hp_X]/mL
CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/mL
CYCLACHAENA XANTHIFOLIA POLLEN - 30 [hp_X]/mL
DACTYLIS GLOMERATA POLLEN - 30 [hp_X]/mL
ECHINACEA, UNSPECIFIED - 3 [hp_X]/mL
FAGUS GRANDIFOLIA POLLEN - 30 [hp_X]/mL
FENUGREEK LEAF - 3 [hp_X]/mL
FESTUCA PRATENSIS POLLEN - 30 [hp_X]/mL
FRAXINUS AMERICANA POLLEN - 30 [hp_X]/mL
GOLDENSEAL - 3 [hp_X]/mL
IVA ANNUA POLLEN - 30 [hp_X]/mL
JUGLANS REGIA POLLEN - 30 [hp_X]/mL
JUNIPERUS ASHEI POLLEN - 30 [hp_X]/mL
JUNIPERUS SCOPULORUM POLLEN - 30 [hp_X]/mL
JUNIPERUS VIRGINIANA POLLEN - 30 [hp_X]/mL
LIGUSTRUM VULGARE POLLEN - 30 [hp_X]/mL
LIQUIDAMBAR STYRACIFLUA POLLEN - 30 [hp_X]/mL
LOLIUM MULTIFLORUM 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
PASCOPYRUM SMITHII POLLEN - 30 [hp_X]/mL
PHALARIS ARUNDINACEA POLLEN - 30 [hp_X]/mL
PHLEUM PRATENSE POLLEN - 30 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT - 3 [hp_X]/mL
PICEA PUNGENS POLLEN - 30 [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 ALBA POLLEN - 30 [hp_X]/mL
POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - 30 [hp_X]/mL
POPULUS NIGRA POLLEN - 30 [hp_X]/mL
POPULUS TREMULOIDES POLLEN - 30 [hp_X]/mL
PSEUDOTSUGA MENZIESII POLLEN - 30 [hp_X]/mL
RUMEX ACETOSELLA POLLEN - 30 [hp_X]/mL
SALIX NIGRA POLLEN - 30 [hp_X]/mL
SALSOLA TRAGUS POLLEN - 30 [hp_X]/mL
SARCOBATUS VERMICULATUS POLLEN - 30 [hp_X]/mL
SOLIDAGO CANADENSIS POLLEN - 30 [hp_X]/mL
SORGHUM HALEPENSE POLLEN - 30 [hp_X]/mL
TRITICUM AESTIVUM POLLEN - 30 [hp_X]/mL
ULMUS AMERICANA POLLEN - 30 [hp_X]/mL
ULMUS PUMILA POLLEN - 30 [hp_X]/mL
URTICA DIOICA POLLEN - 30 [hp_X]/mL
XANTHIUM STRUMARIUM POLLEN - 30 [hp_X]/mL
ZEA MAYS 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:700NK45C76
V38QUQ7861
HU8V6E7HOA
2A64U81OQ3
Z0F2YK1B7H
73B14PX5FW
380W4HYR6N
92N6W6KO2G
U2AI3H2J5Y
2KIK19R45Y
81GS97HVFO
57KIJ4772H
YI19RB8YFD
ANT994T71D
26U0BU8G83
GG8WX068MX
A7IKY24TR7
5EF0HWI5WU
07A108ZKW5
93963RFO1P
766QT72BK6
G2A764T54B
68R9X9Y96X
098LKX5NCN
V80TPZ0T6J
83N78IDA7P
4N9P6CC1DX
34X886W1H4
487RI96K8Z
A0WFQ8P6N1
G684LX721Q
ZW3Z11D0JV
Y2U5S5PF22
ARW43087I1
544F8MEY0Y
0G82TT8ZFY
PY0JA16R2G
Y3FRX92Z0E
5Q246DS5BS
VJI0WKK736
4T81LB52R0
3I9T68187H
JC71GJ1F3L
YH89GMV676
6AU0ZD8T1O
FAY1Y90VJ9
65M88RW2EG
11E6VI8VEG
R9JBC6687X
TX1ER5UV3T
DO87T1U2CI
E03U1K03LK
SCB8J7LS3T
VU8C8SB23P
5928LJ1441
0MGE63QPFJ
928OC2TJDA
ZEI09763J3
N52MIQ81ZW
6M2JIH93ZN
V174354MDI
6532U64A3X
644CZ16IR5
577VA5B4HP
F1KAH8374D
89BAT511BD
030R993R8E
DNB59M1NVU
2QOF601J1M
74PD8J616H
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]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
62713-823-0130 mL in 1 BOTTLE, DROPPER (62713-823-01)01 Jan, 2004N/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 8 echinacea, baptisia tinctoria, hydrastis canadensis, myrrha, nasturtium aquaticum, phytolacca decandra, trigonella foenum-graecum, zone 8 tree, zone 8 weed, zone 8 grass water glycerin 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 alnus rubra pollen alnus rubra pollen fraxinus americana pollen fraxinus americana pollen populus tremuloides pollen populus tremuloides pollen fagus grandifolia pollen fagus grandifolia pollen betula nigra pollen betula nigra pollen juniperus ashei pollen juniperus ashei pollen juniperus virginiana pollen juniperus virginiana pollen populus deltoides subsp. monilifera pollen populus deltoides subsp. monilifera pollen ulmus americana pollen ulmus americana pollen ulmus pumila pollen ulmus pumila pollen pseudotsuga menziesii pollen pseudotsuga menziesii pollen celtis occidentalis pollen celtis occidentalis pollen carya alba pollen carya alba pollen juniperus scopulorum pollen juniperus scopulorum pollen acer saccharum pollen acer saccharum pollen acer rubrum pollen acer rubrum pollen morus alba pollen morus alba pollen pinus strobus pollen pinus strobus pollen populus nigra pollen populus nigra pollen populus alba pollen populus alba pollen ligustrum vulgare pollen ligustrum vulgare pollen picea pungens pollen picea pungens pollen liquidambar styraciflua pollen liquidambar styraciflua pollen platanus occidentalis pollen platanus occidentalis pollen ailanthus altissima pollen ailanthus altissima pollen juglans regia pollen juglans regia pollen salix nigra pollen salix nigra pollen xanthium strumarium pollen xanthium strumarium pollen bassia scoparia pollen bassia scoparia pollen solidago canadensis pollen solidago canadensis pollen sarcobatus vermiculatus pollen sarcobatus vermiculatus pollen chenopodium album pollen chenopodium album pollen cyclachaena xanthifolia pollen cyclachaena xanthifolia pollen iva annua pollen iva annua pollen artemisia vulgaris pollen artemisia vulgaris pollen urtica dioica pollen urtica dioica pollen amaranthus retroflexus pollen amaranthus retroflexus pollen amaranthus spinosus pollen amaranthus spinosus pollen plantago lanceolata pollen plantago lanceolata pollen ambrosia acanthicarpa pollen ambrosia acanthicarpa pollen artemisia tridentata pollen artemisia tridentata pollen artemisia ludoviciana pollen artemisia ludoviciana pollen atriplex confertifolia pollen atriplex confertifolia pollen rumex acetosella pollen rumex acetosella pollen salsola tragus pollen salsola tragus pollen amaranthus tuberculatus pollen amaranthus tuberculatus pollen atriplex canescens pollen atriplex canescens pollen artemisia absinthium pollen artemisia absinthium pollen bromus inermis pollen bromus inermis pollen phalaris arundinacea pollen phalaris arundinacea pollen zea mays pollen zea mays pollen lolium multiflorum pollen lolium multiflorum pollen sorghum halepense pollen sorghum halepense pollen poa pratensis pollen poa pratensis pollen festuca pratensis pollen festuca pratensis pollen avena sativa pollen avena sativa pollen dactylis glomerata pollen dactylis glomerata pollen agrostis gigantea pollen agrostis gigantea pollen lolium perenne pollen lolium perenne pollen phleum pratense pollen phleum pratense pollen anthoxanthum odoratum pollen anthoxanthum odoratum pollen triticum aestivum pollen triticum aestivum pollen pascopyrum smithii pollen pascopyrum smithii 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.

Dosage and Administration:

Directions: •shake well before use. • adults (12 and older) 10-15 drops under the tongue three times daily. • children (2-12) 6-10 drops under the tongue three times daily. • infants (0-2) 3-6 drops under the toung three times daily or as directed by your health care professional.

Package Label Principal Display Panel:

*www.allergena.com/drugdisclaimer **standard antigen mix used in this product is cross-reactive with zone 8 tree, weed, and grass allergens. 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.