| Drug NDC: | 62713-951 |
| 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 Texas Cedar Fever |
| 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: | Texas Cedar Fever |
| 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, Texas Tree, Texas Weed, Texas 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: | 01 Feb, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 08 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: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| UNII: | |
| 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: | 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 |
|---|---|---|---|---|
| 62713-951-01 | 30 mL in 1 BOTTLE, DROPPER (62713-951-01) | 01 Feb, 2020 | N/A | No |
| 62713-951-02 | 59 mL in 1 BOTTLE, DROPPER (62713-951-02) | 01 Feb, 2020 | N/A | No |
| 62713-951-03 | 118 mL in 1 BOTTLE, DROPPER (62713-951-03) | 01 Feb, 2020 | 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. | ||||
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