| Drug NDC: | 62713-801 |
| 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 1 |
| 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 1 |
| 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 1 Tree, Zone 1 Weed, Zone 1 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 NEGUNDO 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 INCANA SUBSP. RUGOSA POLLEN - 30 [hp_X]/mL AMARANTHUS PALMERI POLLEN - 30 [hp_X]/mL AMARANTHUS SPINOSUS POLLEN - 30 [hp_X]/mL AMARANTHUS TUBERCULATUS POLLEN - 30 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA POLLEN - 30 [hp_X]/mL AMBROSIA PSILOSTACHYA POLLEN - 30 [hp_X]/mL Load more... AMBROSIA TRIFIDA POLLEN - 30 [hp_X]/mL ANTHOXANTHUM ODORATUM POLLEN - 30 [hp_X]/mL ARTEMISIA ABSINTHIUM POLLEN - 30 [hp_X]/mL ARTEMISIA ANNUA POLLEN - 30 [hp_X]/mL ARTEMISIA VULGARIS POLLEN - 30 [hp_X]/mL AVENA SATIVA POLLEN - 30 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 3 [hp_X]/mL BETULA NIGRA POLLEN - 30 [hp_X]/mL BETULA POPULIFOLIA 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 CELTIS OCCIDENTALIS POLLEN - 30 [hp_X]/mL CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/mL CHENOPODIUM AMBROSIOIDES 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 FAGUS GRANDIFOLIA POLLEN - 30 [hp_X]/mL FENUGREEK LEAF - 3 [hp_X]/mL FESTUCA PRATENSIS TOP - 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 HOLCUS LANATUS 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 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 POPULUS ALBA POLLEN - 30 [hp_X]/mL POPULUS NIGRA POLLEN - 30 [hp_X]/mL POPULUS TREMULOIDES POLLEN - 30 [hp_X]/mL QUERCUS ALBA POLLEN - 30 [hp_X]/mL QUERCUS STELLATA POLLEN - 30 [hp_X]/mL QUERCUS VELUTINA POLLEN - 30 [hp_X]/mL RUMEX ACETOSELLA POLLEN - 30 [hp_X]/mL RUMEX CRISPUS POLLEN - 30 [hp_X]/mL SALIX NIGRA POLLEN - 30 [hp_X]/mL SOLIDAGO CANADENSIS POLLEN - 30 [hp_X]/mL SORGHUM HALEPENSE POLLEN - 30 [hp_X]/mL SORGHUM X DRUMMONDII POLLEN - 30 [hp_X]/mL TRITICUM AESTIVUM POLLEN - 30 [hp_X]/mL ULMUS AMERICANA POLLEN - 30 [hp_X]/mL URTICA DIOICA POLLEN - 30 [hp_X]/mL XANTHIUM STRUMARIUM VAR. CANADENSE 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: | 01 Jan, 1987 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 09 May, 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. | |
| 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: | P6K070AR8V V38QUQ7861 HU8V6E7HOA 2A64U81OQ3 605T96G8Y5 1GH3WV23KH 380W4HYR6N 92N6W6KO2G K20Y81ACO3 RX18M46K8L Load more... KU1V1898XX 2KIK19R45Y 81GS97HVFO 36R82U4DL6 ANT994T71D A7IKY24TR7 5EF0HWI5WU 93963RFO1P 23H70FYJ5U 766QT72BK6 51I6N3XIML G2A764T54B 68R9X9Y96X 098LKX5NCN WIB701MW2H 175F461W10 83N78IDA7P 4N9P6CC1DX 34X886W1H4 487RI96K8Z DQE6KXZ5JR G684LX721Q 2WZG2G15WX LJT6I6Z8FD ZW3Z11D0JV 70O1TP6H01 1BV28146ZR 544F8MEY0Y PY0JA16R2G IIC6H3WF6J Y3FRX92Z0E 5Q246DS5BS VJI0WKK736 4T81LB52R0 3I9T68187H 9LYI4RTZ52 JC71GJ1F3L YH89GMV676 FAY1Y90VJ9 65M88RW2EG 11E6VI8VEG R9JBC6687X TX1ER5UV3T DO87T1U2CI E03U1K03LK VU8C8SB23P 0MGE63QPFJ 928OC2TJDA Z4Y9ZSV4KK W34X0P8636 294L626TT0 N52MIQ81ZW V825XJG64G 6M2JIH93ZN 644CZ16IR5 577VA5B4HP B43R30VP73 F1KAH8374D 89BAT511BD DNB59M1NVU 0ZK6G3W3BI 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. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 62713-801-01 | 30 mL in 1 BOTTLE, DROPPER (62713-801-01) | 01 Jan, 2004 | N/A | No |
| 62713-801-02 | 59 mL in 1 BOTTLE, DROPPER (62713-801-02) | 01 Jan, 2004 | 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.