Texaclear All Season Allergy Relief Solution/ Drops
NDC 58809-213

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58809-213?
  4. Texaclear All Season Allergy Relief Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Texaclear All Season Allergy Relief (antigens all zones grasses trees and weeds. baptisia tinctoria, echinacea, hydrastis canadensis, myrrha, nasturtium aquaticum, phytolacca decandra, urtica urens) is a UNAPPROVED HOMEOPATHIC-approved product labeled by Gm Pharmaceuticals, Inc. This medication is typically used as a allergens [cs]. It is supplied as a solution/ drops for sublingual administration. This product entry covers the primary NDC 58809-213 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58809-213
Proprietary Name:
Texaclear All Season Allergy Relief
Non-Proprietary Name: [1]
Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens
Substance Name: [2]
Holcus Lanatus Pollen; Morus Rubra Pollen; Pinus Strobus Pollen; Nasturtium Officinale; Amaranthus Spinosus Pollen; Fraxinus Americana Pollen; Juglans Nigra Pollen; Juniperus Virginiana Pollen; Platanus Occidentalis Pollen; Populus Deltoides Subsp. Deltoides Pollen; Populus Deltoides Subsp. Monilifera Pollen; Quercus Rubra Pollen; Sorghum Halepense Pollen; Triticum Aestivum Pollen; Urtica Dioica Pollen; Ambrosia Psilostachya Pollen; Rumex Crispus Pollen; Secale Cereale Pollen; Taxodium Distichum Pollen; Xanthium Strumarium Pollen; Quercus Nigra Pollen; Quercus Stellata Pollen; Solidago Canadensis Pollen; Amaranthus Retroflexus Pollen; Ambrosia Confertiflora Pollen; Eucalyptus Globulus Pollen; Myrrh; Salsola Kali Pollen; Quercus Macrocarpa Pollen; Syagrus Romanzoffiana Pollen; Zea Mays Pollen; Chenopodium Album Pollen; Artemisia Tridentata Pollen; Goldenseal; Fagus Grandifolia Pollen; Fraxinus Velutina Pollen; Broussonetia Papyrifera Pollen; Pinus Echinata Pollen; Urtica Urens Whole; Amaranthus Palmeri Pollen; Amaranthus Tuberculatus Pollen; Carya Illinoinensis Pollen; Liquidambar Styraciflua Pollen; Melaleuca Quinquenervia Pollen; Morus Alba Pollen; Hesperocyparis Arizonica Pollen; Juniperus Occidentalis Pollen; Olea Europaea Pollen; Echinacea Angustifolia Root; Acer Saccharum Pollen; Anthoxanthum Odoratum Pollen; Avena Sativa Pollen; Phytolacca Americana Root; Baptisia Tinctoria Root; Acer Negundo Pollen; Ambrosia Acanthicarpa Pollen; Ambrosia Artemisiifolia Pollen; Ambrosia Trifida Pollen; Artemisia Vulgaris Pollen; Carya Ovata Pollen; Celtis Occidentalis Pollen; Cyclachaena Xanthifolia Pollen; Juniperus Ashei Pollen; Ligustrum Vulgare Pollen; Myrica Cerifera Pollen; Poa Pratensis Pollen; Populus Alba Pollen; Rumex Acetosella Pollen; Salix Nigra Pollen; Schinus Molle Pollen; Acacia Dealbata Pollen; Atriplex Wrightii Pollen; Paspalum Notatum Pollen; Populus Nigra Pollen; Quercus Alba Pollen; Quercus Gambelii Pollen; Plantago Lanceolata Pollen; Prosopis Juliflora Pollen; Quercus Virginiana Pollen; Ulmus Americana Pollen; Ambrosia Bidentata Pollen; Bassia Scoparia Pollen; Betula Nigra Pollen; Distichlis Spicata Pollen; Eupatorium Capillifolium Pollen
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
Sublingual - Administration beneath the tongue.

Labeler & Regulatory Data

Labeler Name: [5]
Gm Pharmaceuticals, Inc
Labeler Code:
58809
Product Label ID:
065d16e7-87f4-ecaa-e063-6294a90abca7
Marketing Category: [8]
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.

Marketing Timeline

Start Marketing Date: [9]
11-10-2023
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 58809-213?

The NDC code 58809-213 is assigned by the FDA to the product Texaclear All Season Allergy Relief. It is commonly known by its generic name, antigens all zones grasses trees and weeds. baptisia tinctoria, echinacea, hydrastis canadensis, myrrha, nasturtium aquaticum, phytolacca decandra, urtica urens. This pharmaceutical product is labeled by Gm Pharmaceuticals, Inc and is currently categorized as listed product. The medication is a solution/ drops administered via sublingual route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 58809-213-01, 58809-213-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Measure only with enclosed dropper provided.Adults 12 years and older: 10-15 drops, 3 times per day, hold under the tongue for at least 30 seconds before swallowing.Consult a doctor for use in children under 12

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI)
  • PLANTAGO LANCEOLATA POLLEN (UNII: DO87T1U2CI) (Active Moiety)
  • PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR)
  • PROSOPIS JULIFLORA POLLEN (UNII: 6EIJ3D04MR) (Active Moiety)
  • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO)
  • QUERCUS VIRGINIANA POLLEN (UNII: 8KDG09A4GO) (Active Moiety)
  • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD)
  • ULMUS AMERICANA POLLEN (UNII: 89BAT511BD) (Active Moiety)
  • AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O)
  • AMBROSIA BIDENTATA POLLEN (UNII: M3S672G75O) (Active Moiety)
  • BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5)
  • BASSIA SCOPARIA POLLEN (UNII: 07A108ZKW5) (Active Moiety)
  • BETULA NIGRA POLLEN (UNII: 93963RFO1P)
  • BETULA NIGRA POLLEN (UNII: 93963RFO1P) (Active Moiety)
  • DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV)
  • DISTICHLIS SPICATA POLLEN (UNII: GOA51670YV) (Active Moiety)
  • EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0)
  • EUPATORIUM CAPILLIFOLIUM POLLEN (UNII: B67NF86HF0) (Active Moiety)
  • HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01)
  • HOLCUS LANATUS POLLEN (UNII: 70O1TP6H01) (Active Moiety)
  • MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52)
  • MORUS RUBRA POLLEN (UNII: 9LYI4RTZ52) (Active Moiety)
  • PINUS STROBUS POLLEN (UNII: TX1ER5UV3T)
  • PINUS STROBUS POLLEN (UNII: TX1ER5UV3T) (Active Moiety)
  • NASTURTIUM OFFICINALE (UNII: YH89GMV676)
  • NASTURTIUM OFFICINALE (UNII: YH89GMV676) (Active Moiety)
  • AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N)
  • AMARANTHUS SPINOSUS POLLEN (UNII: 380W4HYR6N) (Active Moiety)
  • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q)
  • FRAXINUS AMERICANA POLLEN (UNII: G684LX721Q) (Active Moiety)
  • JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR)
  • JUGLANS NIGRA POLLEN (UNII: 1BV28146ZR) (Active Moiety)
  • JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G)
  • JUNIPERUS VIRGINIANA POLLEN (UNII: PY0JA16R2G) (Active Moiety)
  • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK)
  • PLATANUS OCCIDENTALIS POLLEN (UNII: E03U1K03LK) (Active Moiety)
  • POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN (UNII: 476DVV63WP)
  • POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN (UNII: 476DVV63WP) (Active Moiety)
  • POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441)
  • POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN (UNII: 5928LJ1441) (Active Moiety)
  • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C)
  • QUERCUS RUBRA POLLEN (UNII: SVW19ET93C) (Active Moiety)
  • SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP)
  • SORGHUM HALEPENSE POLLEN (UNII: 577VA5B4HP) (Active Moiety)
  • TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D)
  • TRITICUM AESTIVUM POLLEN (UNII: F1KAH8374D) (Active Moiety)
  • URTICA DIOICA POLLEN (UNII: DNB59M1NVU)
  • URTICA DIOICA POLLEN (UNII: DNB59M1NVU) (Active Moiety)
  • AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L)
  • AMBROSIA PSILOSTACHYA POLLEN (UNII: RX18M46K8L) (Active Moiety)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G)
  • RUMEX CRISPUS POLLEN (UNII: V825XJG64G) (Active Moiety)
  • SECALE CEREALE POLLEN (UNII: I6KAZ8AO1O)
  • SECALE CEREALE POLLEN (UNII: I6KAZ8AO1O) (Active Moiety)
  • TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R)
  • TAXODIUM DISTICHUM POLLEN (UNII: O12H03B41R) (Active Moiety)
  • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M)
  • XANTHIUM STRUMARIUM POLLEN (UNII: 2QOF601J1M) (Active Moiety)
  • QUERCUS NIGRA POLLEN (UNII: 6U600U1326)
  • QUERCUS NIGRA POLLEN (UNII: 6U600U1326) (Active Moiety)
  • QUERCUS STELLATA POLLEN (UNII: W34X0P8636)
  • QUERCUS STELLATA POLLEN (UNII: W34X0P8636) (Active Moiety)
  • SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5)
  • SOLIDAGO CANADENSIS POLLEN (UNII: 644CZ16IR5) (Active Moiety)
  • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW)
  • AMARANTHUS RETROFLEXUS POLLEN (UNII: 73B14PX5FW) (Active Moiety)
  • AMBROSIA CONFERTIFLORA POLLEN (UNII: 63TBJ590BL)
  • AMBROSIA CONFERTIFLORA POLLEN (UNII: 63TBJ590BL) (Active Moiety)
  • EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9)
  • EUCALYPTUS GLOBULUS POLLEN (UNII: 7XW7TB10X9) (Active Moiety)
  • MYRRH (UNII: JC71GJ1F3L)
  • MYRRH (UNII: JC71GJ1F3L) (Active Moiety)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G)
  • SALSOLA KALI POLLEN (UNII: 2MH135KC6G) (Active Moiety)
  • QUERCUS MACROCARPA POLLEN (UNII: 57BTU4547U)
  • QUERCUS MACROCARPA POLLEN (UNII: 57BTU4547U) (Active Moiety)
  • SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB)
  • SYAGRUS ROMANZOFFIANA POLLEN (UNII: 84ZOM591BB) (Active Moiety)
  • ZEA MAYS POLLEN (UNII: 74PD8J616H)
  • ZEA MAYS POLLEN (UNII: 74PD8J616H) (Active Moiety)
  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN)
  • CHENOPODIUM ALBUM POLLEN (UNII: 098LKX5NCN) (Active Moiety)
  • ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD)
  • ARTEMISIA TRIDENTATA POLLEN (UNII: YI19RB8YFD) (Active Moiety)
  • GOLDENSEAL (UNII: ZW3Z11D0JV)
  • GOLDENSEAL (UNII: ZW3Z11D0JV) (Active Moiety)
  • FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4)
  • FAGUS GRANDIFOLIA POLLEN (UNII: 34X886W1H4) (Active Moiety)
  • FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD)
  • FRAXINUS VELUTINA POLLEN (UNII: LJT6I6Z8FD) (Active Moiety)
  • BROUSSONETIA PAPYRIFERA POLLEN (UNII: 51I6N3XIML)
  • BROUSSONETIA PAPYRIFERA POLLEN (UNII: 51I6N3XIML) (Active Moiety)
  • PINUS ECHINATA POLLEN (UNII: 96LRW14765)
  • PINUS ECHINATA POLLEN (UNII: 96LRW14765) (Active Moiety)
  • URTICA URENS WHOLE (UNII: IHN2NQ5OF9)
  • URTICA URENS WHOLE (UNII: IHN2NQ5OF9) (Active Moiety)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH)
  • AMARANTHUS PALMERI POLLEN (UNII: 1GH3WV23KH) (Active Moiety)
  • AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G)
  • AMARANTHUS TUBERCULATUS POLLEN (UNII: 92N6W6KO2G) (Active Moiety)
  • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y)
  • CARYA ILLINOINENSIS POLLEN (UNII: PYO4JR720Y) (Active Moiety)
  • LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS)
  • LIQUIDAMBAR STYRACIFLUA POLLEN (UNII: 5Q246DS5BS) (Active Moiety)
  • MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E)
  • MELALEUCA QUINQUENERVIA POLLEN (UNII: NX974IRT8E) (Active Moiety)
  • MORUS ALBA POLLEN (UNII: 3I9T68187H)
  • MORUS ALBA POLLEN (UNII: 3I9T68187H) (Active Moiety)
  • HESPEROCYPARIS ARIZONICA POLLEN (UNII: 232DMH0XVF)
  • HESPEROCYPARIS ARIZONICA POLLEN (UNII: 232DMH0XVF) (Active Moiety)
  • JUNIPERUS OCCIDENTALIS POLLEN (UNII: 7JWJ3HXZ9U)
  • JUNIPERUS OCCIDENTALIS POLLEN (UNII: 7JWJ3HXZ9U) (Active Moiety)
  • OLEA EUROPAEA POLLEN (UNII: 43R41XZ627)
  • OLEA EUROPAEA POLLEN (UNII: 43R41XZ627) (Active Moiety)
  • ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)
  • ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P) (Active Moiety)
  • ACER SACCHARUM POLLEN (UNII: V38QUQ7861)
  • ACER SACCHARUM POLLEN (UNII: V38QUQ7861) (Active Moiety)
  • ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y)
  • ANTHOXANTHUM ODORATUM POLLEN (UNII: 2KIK19R45Y) (Active Moiety)
  • AVENA SATIVA POLLEN (UNII: A7IKY24TR7)
  • AVENA SATIVA POLLEN (UNII: A7IKY24TR7) (Active Moiety)
  • PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
  • PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (Active Moiety)
  • BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU)
  • BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (Active Moiety)
  • ACER NEGUNDO POLLEN (UNII: P6K070AR8V)
  • ACER NEGUNDO POLLEN (UNII: P6K070AR8V) (Active Moiety)
  • AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y)
  • AMBROSIA ACANTHICARPA POLLEN (UNII: U2AI3H2J5Y) (Active Moiety)
  • AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3)
  • AMBROSIA ARTEMISIIFOLIA POLLEN (UNII: K20Y81ACO3) (Active Moiety)
  • AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX)
  • AMBROSIA TRIFIDA POLLEN (UNII: KU1V1898XX) (Active Moiety)
  • ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D)
  • ARTEMISIA VULGARIS POLLEN (UNII: ANT994T71D) (Active Moiety)
  • CARYA OVATA POLLEN (UNII: 54UN9R2798)
  • CARYA OVATA POLLEN (UNII: 54UN9R2798) (Active Moiety)
  • CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X)
  • CELTIS OCCIDENTALIS POLLEN (UNII: 68R9X9Y96X) (Active Moiety)
  • CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J)
  • CYCLACHAENA XANTHIFOLIA POLLEN (UNII: V80TPZ0T6J) (Active Moiety)
  • JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y)
  • JUNIPERUS ASHEI POLLEN (UNII: 544F8MEY0Y) (Active Moiety)
  • LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E)
  • LIGUSTRUM VULGARE POLLEN (UNII: Y3FRX92Z0E) (Active Moiety)
  • MYRICA CERIFERA POLLEN (UNII: LC8MEV9S89)
  • MYRICA CERIFERA POLLEN (UNII: LC8MEV9S89) (Active Moiety)
  • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T)
  • POA PRATENSIS POLLEN (UNII: SCB8J7LS3T) (Active Moiety)
  • POPULUS ALBA POLLEN (UNII: VU8C8SB23P)
  • POPULUS ALBA POLLEN (UNII: VU8C8SB23P) (Active Moiety)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW)
  • RUMEX ACETOSELLA POLLEN (UNII: N52MIQ81ZW) (Active Moiety)
  • SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN)
  • SALIX NIGRA POLLEN (UNII: 6M2JIH93ZN) (Active Moiety)
  • SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1)
  • SCHINUS MOLLE POLLEN (UNII: M0G28FH9K1) (Active Moiety)
  • ACACIA DEALBATA POLLEN (UNII: L16Z5HLP8V)
  • ACACIA DEALBATA POLLEN (UNII: L16Z5HLP8V) (Active Moiety)
  • ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O)
  • ATRIPLEX WRIGHTII POLLEN (UNII: YB1308W43O) (Active Moiety)
  • PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK)
  • PASPALUM NOTATUM POLLEN (UNII: V003SHB7VK) (Active Moiety)
  • POPULUS NIGRA POLLEN (UNII: 0MGE63QPFJ)
  • POPULUS NIGRA POLLEN (UNII: 0MGE63QPFJ) (Active Moiety)
  • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK)
  • QUERCUS ALBA POLLEN (UNII: Z4Y9ZSV4KK) (Active Moiety)
  • QUERCUS GAMBELII POLLEN (UNII: 9HC15X34LX)
  • QUERCUS GAMBELII POLLEN (UNII: 9HC15X34LX) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".