Drug NDC: | 62713-959 |
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 4 Kids |
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 4 Kids |
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 4 Tree, Zone 4 Weed, Zone 4 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 ACER NEGUNDO POLLEN - 30 [hp_X]/mL ACER RUBRUM POLLEN - 30 [hp_X]/mL ACER SACCHARINUM 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 AMARANTHUS SPINOSUS POLLEN - 30 [hp_X]/mL Load more... AMARANTHUS TUBERCULATUS POLLEN - 30 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA POLLEN - 30 [hp_X]/mL AMBROSIA PSILOSTACHYA POLLEN - 30 [hp_X]/mL AMBROSIA TRIFIDA POLLEN - 30 [hp_X]/mL AMPHIACHYRIS DRACUNCULOIDES POLLEN - 30 [hp_X]/mL ARRHENATHERUM ELATIUS POLLEN - 30 [hp_X]/mL ARTEMISIA ANNUA POLLEN - 30 [hp_X]/mL ARTEMISIA FRIGIDA 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 AVENA SATIVA POLLEN - 30 [hp_X]/mL BACCHARIS HALIMIFOLIA POLLEN - 30 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 3 [hp_X]/mL BASSIA SCOPARIA POLLEN - 30 [hp_X]/mL BETULA LENTA POLLEN - 30 [hp_X]/mL BETULA NIGRA POLLEN - 30 [hp_X]/mL BETULA PAPYRIFERA POLLEN - 30 [hp_X]/mL BROMUS INERMIS POLLEN - 30 [hp_X]/mL BROUSSONETIA PAPYRIFERA POLLEN - 30 [hp_X]/mL CARYA ALBA POLLEN - 30 [hp_X]/mL CARYA CORDIFORMIS POLLEN - 30 [hp_X]/mL CARYA GLABRA POLLEN - 30 [hp_X]/mL CARYA ILLINOINENSIS POLLEN - 30 [hp_X]/mL CARYA OVATA POLLEN - 30 [hp_X]/mL CELTIS OCCIDENTALIS POLLEN - 30 [hp_X]/mL CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/mL CHENOPODIUM AMBROSIOIDES POLLEN - 30 [hp_X]/mL CUPRESSUS ARIZONICA POLLEN - 30 [hp_X]/mL CYCLACHAENA XANTHIFOLIA 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 ELYMUS REPENS POLLEN - 30 [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 FRAXINUS PENNSYLVANICA POLLEN - 30 [hp_X]/mL FRAXINUS VELUTINA POLLEN - 30 [hp_X]/mL GOLDENSEAL - 3 [hp_X]/mL IVA ANGUSTIFOLIA POLLEN - 30 [hp_X]/mL IVA ANNUA POLLEN - 30 [hp_X]/mL JUGLANS NIGRA POLLEN - 30 [hp_X]/mL JUNIPERUS ASHEI POLLEN - 30 [hp_X]/mL JUNIPERUS VIRGINIANA POLLEN - 30 [hp_X]/mL KOELERIA MACRANTHA 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 MORUS RUBRA 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 NIGRA POLLEN - 30 [hp_X]/mL PINUS SYLVESTRIS POLLEN - 30 [hp_X]/mL PINUS TAEDA POLLEN - 30 [hp_X]/mL PLANTAGO LANCEOLATA POLLEN - 30 [hp_X]/mL PLATANUS OCCIDENTALIS POLLEN - 30 [hp_X]/mL POA ANNUA POLLEN - 30 [hp_X]/mL POPULUS ALBA POLLEN - 30 [hp_X]/mL POPULUS DELTOIDES POLLEN - 30 [hp_X]/mL POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - 30 [hp_X]/mL POPULUS NIGRA POLLEN - 30 [hp_X]/mL PROSOPIS JULIFLORA POLLEN - 30 [hp_X]/mL QUERCUS ALBA POLLEN - 30 [hp_X]/mL QUERCUS MACROCARPA POLLEN - 30 [hp_X]/mL QUERCUS RUBRA POLLEN - 30 [hp_X]/mL QUERCUS STELLATA POLLEN - 30 [hp_X]/mL QUERCUS VELUTINA POLLEN - 30 [hp_X]/mL RUMEX CRISPUS POLLEN - 30 [hp_X]/mL RUMEX OBTUSIFOLIUS POLLEN - 30 [hp_X]/mL SALIX NIGRA POLLEN - 30 [hp_X]/mL SALSOLA TRAGUS POLLEN - 30 [hp_X]/mL SOLIDAGO CANADENSIS POLLEN - 30 [hp_X]/mL SORGHUM BICOLOR POLLEN - 30 [hp_X]/mL SORGHUM HALEPENSE POLLEN - 30 [hp_X]/mL SORGHUM X DRUMMONDII POLLEN - 30 [hp_X]/mL TAXODIUM DISTICHUM POLLEN - 30 [hp_X]/mL TRITICUM AESTIVUM POLLEN - 30 [hp_X]/mL ULMUS AMERICANA POLLEN - 30 [hp_X]/mL ULMUS CRASSIFOLIA 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 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: | 15 Mar, 2021 |
This is the date that the labeler indicates was the start of its marketing of the drug product. | |
Marketing End Date: | 15 Jan, 2025 |
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. |
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 P6K070AR8V 700NK45C76 95447163DG HU8V6E7HOA 2A64U81OQ3 605T96G8Y5 1GH3WV23KH 73B14PX5FW 380W4HYR6N Load more... 92N6W6KO2G K20Y81ACO3 RX18M46K8L KU1V1898XX 83X1I1RR5F B55BD1QM4Q 36R82U4DL6 5AN5LR8L3F YI19RB8YFD ANT994T71D 26U0BU8G83 A7IKY24TR7 BBO1IJ3ZIW 5EF0HWI5WU 07A108ZKW5 JQ5HI5004M 93963RFO1P 3538FNV8AY 766QT72BK6 51I6N3XIML G2A764T54B O99P60FU6G KPO1Z9N98A PYO4JR720Y 54UN9R2798 68R9X9Y96X 098LKX5NCN WIB701MW2H 232DMH0XVF V80TPZ0T6J 175F461W10 83N78IDA7P 4N9P6CC1DX ON2T85TA2O 34X886W1H4 487RI96K8Z A0WFQ8P6N1 G684LX721Q 2WZG2G15WX LJT6I6Z8FD ZW3Z11D0JV UBW6O1H50I Y2U5S5PF22 1BV28146ZR 544F8MEY0Y PY0JA16R2G IIC6H3WF6J Y3FRX92Z0E 5Q246DS5BS VJI0WKK736 4T81LB52R0 3I9T68187H 9LYI4RTZ52 JC71GJ1F3L YH89GMV676 6AU0ZD8T1O FAY1Y90VJ9 65M88RW2EG 11E6VI8VEG R9JBC6687X 17Q05812N1 59070I8M63 4O1FFR8ARN DO87T1U2CI E03U1K03LK 7U437HHU5C VU8C8SB23P 476DVV63WP 5928LJ1441 0MGE63QPFJ 6EIJ3D04MR Z4Y9ZSV4KK 57BTU4547U SVW19ET93C W34X0P8636 294L626TT0 V825XJG64G R6H8O3GVL9 6M2JIH93ZN V174354MDI 644CZ16IR5 LD795V73G4 577VA5B4HP B43R30VP73 O12H03B41R F1KAH8374D 89BAT511BD G82398SD3I 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] |
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
---|---|---|---|---|
62713-959-01 | 30 mL in 1 BOTTLE, DROPPER (62713-959-01) | 15 Mar, 2021 | N/A | No |
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. |
* 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.