58809-213-02 NDC Code

Detailed Information

Field Name	Field Value	Field Description
NDC Package Code	58809-213-02	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	60 ML IN 1 BOTTLE, DROPPER (58809-213-02)	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Proprietary Name	TEXACLEAR ALL SEASON ALLERGY RELIEF	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	ANTIGENS ALL ZONES GRASSES TREES AND WEEDS. BAPTISIA TINCTORIA, ECHINACEA, HYDRASTIS CANADENSIS, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, URTICA URENS	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Substance Name	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	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Dosage Form Name	SOLUTION/ DROPS	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	SUBLINGUAL	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.
Status	ACTIVE	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Last Update Date	2025-12-16	The date that a record was last updated or changed.
Labeler Name	GM PHARMACEUTICALS, INC	Name of Company corresponding to the labeler code segment of the ProductNDC.
Pharmaceutical Classes	ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], ALLERGENS [CS], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], CELL-MEDIATED IMMUNITY [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE], INCREASED HISTAMINE RELEASE [PE]	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.
Strength Number	6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 5; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6	These are the strength values (to be used with units below) of each active ingredient, listed in the same order as the SubstanceName field above.
Strength Unit	[HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML; [HP_X]/ML	These are the units to be used with the strength values above, listed in the same order as the SubstanceName and SubstanceNumber.
11 Digit NDC Code	58809-0213-02	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Product NDC	58809-213	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.
Product Type Name	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. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Category Name	UNAPPROVED HOMEOPATHIC	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.
Package Start Marketing Date	20231110	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package NDC Exclude Flag	N	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Product NDC Exclude Flag	N	This 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.
Listing Record Certified Through	20261231	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20231110	This is the date that the labeler indicates was the start of its marketing of the drug product.
Sample Package	N	Defines whether given package serves sample purposes.

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