| Drug NDC: | 59623-001 |
| 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: | Seasonal Allergy Formula |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| 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: | Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Integrative Healing Institute, Llc |
| 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 - 6 [hp_X]/mL ACER RUBRUM POLLEN - 6 [hp_X]/mL ACER SACCHARINUM POLLEN - 6 [hp_X]/mL ACER SACCHARUM POLLEN - 6 [hp_X]/mL ALNUS RUBRA POLLEN - 6 [hp_X]/mL AMARANTHUS RETROFLEXUS POLLEN - 6 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA POLLEN - 6 [hp_X]/mL ANTHOXANTHUM ODORATUM - 6 [hp_X]/mL ARTEMISIA VULGARIS POLLEN - 6 [hp_X]/mL BARLEY - 6 [hp_X]/mL Load more... BETULA LENTA POLLEN - 6 [hp_X]/mL BETULA NIGRA POLLEN - 6 [hp_X]/mL BETULA PAPYRIFERA POLLEN - 6 [hp_X]/mL BETULA PUBESCENS FLOWER BUD - 6 [hp_X]/mL BROMUS SECALINUS POLLEN - 6 [hp_X]/mL CARYA ALBA POLLEN - 6 [hp_X]/mL CARYA GLABRA POLLEN - 6 [hp_X]/mL CARYA LACINIOSA POLLEN - 6 [hp_X]/mL CARYA OVATA POLLEN - 6 [hp_X]/mL CYNODON DACTYLON POLLEN - 6 [hp_X]/mL FRAXINUS AMERICANA POLLEN - 6 [hp_X]/mL FRAXINUS PENNSYLVANICA POLLEN - 6 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 12 [hp_C]/mL GOLDENSEAL - 4 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 30 [hp_C]/mL HOUSE DUST - 12 [hp_X]/mL JUGLANS REGIA POLLEN - 6 [hp_X]/mL JUNIPERUS VIRGINIANA POLLEN - 6 [hp_X]/mL MELILOTUS OFFICINALIS TOP - 6 [hp_X]/mL MORUS RUBRA POLLEN - 6 [hp_X]/mL PHLEUM PRATENSE TOP - 6 [hp_X]/mL PINUS NIGRA POLLEN - 6 [hp_X]/mL PINUS STROBUS POLLEN - 6 [hp_X]/mL PINUS SYLVESTRIS POLLEN - 6 [hp_X]/mL PINUS TAEDA POLLEN - 6 [hp_X]/mL PLANTAGO LANCEOLATA POLLEN - 6 [hp_X]/mL PLATANUS OCCIDENTALIS POLLEN - 6 [hp_X]/mL POA PRATENSIS POLLEN - 6 [hp_X]/mL POPULUS ALBA POLLEN - 6 [hp_X]/mL POTASSIUM CHLORIDE - 6 [hp_X]/mL POTASSIUM DICHROMATE - 12 [hp_C]/mL QUERCUS ALBA POLLEN - 6 [hp_X]/mL QUERCUS MACROCARPA POLLEN - 6 [hp_X]/mL QUERCUS MARILANDICA POLLEN - 6 [hp_X]/mL QUERCUS RUBRA POLLEN - 6 [hp_X]/mL QUERCUS STELLATA POLLEN - 6 [hp_X]/mL RUMEX ACETOSELLA POLLEN - 6 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED - 12 [hp_C]/mL SOLIDAGO VIRGAUREA POLLEN - 6 [hp_X]/mL SORGHUM HALEPENSE POLLEN - 6 [hp_X]/mL TRITICUM AESTIVUM POLLEN - 6 [hp_X]/mL ULMUS AMERICANA POLLEN - 6 [hp_X]/mL ULMUS PUMILA POLLEN - 6 [hp_X]/mL ULMUS RUBRA POLLEN - 6 [hp_X]/mL ZEA MAYS POLLEN - 6 [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: | 22 Jul, 2013 |
| 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: | Integrative Healing Institute, LLC |
| 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 N0000185371 M0006342 N0000185016 N0000185374 M0006896 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | P6K070AR8V 700NK45C76 95447163DG V38QUQ7861 Z0F2YK1B7H 73B14PX5FW K20Y81ACO3 YMW1K70E4Q ANT994T71D 5PWM7YLI7R Load more... JQ5HI5004M 93963RFO1P 3538FNV8AY 32JS91VU1G Q4T1SJ3046 G2A764T54B KPO1Z9N98A 5BGG872373 54UN9R2798 175F461W10 G684LX721Q 2WZG2G15WX 639KR60Q1Q ZW3Z11D0JV 3POA0Q644U EYO007VX98 ARW43087I1 PY0JA16R2G GM6P02J2DX 9LYI4RTZ52 S7PW24BX20 17Q05812N1 TX1ER5UV3T 59070I8M63 4O1FFR8ARN DO87T1U2CI E03U1K03LK SCB8J7LS3T VU8C8SB23P 660YQ98I10 T4423S18FM Z4Y9ZSV4KK 57BTU4547U ZTR043UHDE SVW19ET93C W34X0P8636 N52MIQ81ZW 6NAF1689IO 77K87U8X7J 577VA5B4HP F1KAH8374D 89BAT511BD 030R993R8E GHC6OHK0W0 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] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized House Dust 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] Dietary Proteins [CS] House Dust [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] Dietary Proteins [CS] Grain Proteins [EXT] House Dust [CS] Increased Histamine Release [PE] Increased IgG Production [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 |
|---|---|---|---|---|
| 59623-001-01 | 30 mL in 1 BOTTLE, DROPPER (59623-001-01) | 22 Jul, 2013 | N/A | No |
| 59623-001-02 | 59 mL in 1 BOTTLE, DROPPER (59623-001-02) | 22 Jul, 2013 | 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.