17089-453 NDC - GUNA-COUGH (ALTHAEA OFFICINALIS LEAF - ANTIMONY POTASSIUM TARTRATE - BRYONIA ALBA ROOT - CETRARIA ISLANDICA SUBSP. ISLANDICA - COCHINEAL - COPPER - DROSERA ROTUNDIFOLIA - ECHINACEA ANGUSTIFOLIA - GARDEN THYME - LOBARIA PULMONARIA - PLANTAGO MAJOR -)

Drug Information

  • Product NDC: 17089-453
  • Proprietary Name: GUNA-COUGH
  • Non Proprietary Name: ALTHAEA OFFICINALIS LEAF - ANTIMONY POTASSIUM TARTRATE - BRYONIA ALBA ROOT - CETRARIA ISLANDICA SUBSP. ISLANDICA - COCHINEAL - COPPER - DROSERA ROTUNDIFOLIA - ECHINACEA ANGUSTIFOLIA - GARDEN THYME - LOBARIA PULMONARIA - PLANTAGO MAJOR -
  • Active Ingredient(s): 1 [hp_X]/150mL ALTHAEA OFFICINALIS LEAF; 8 [hp_X]/150mL ANTIMONY POTASSIUM TARTRATE; 6 [hp_X]/150mL BRYONIA ALBA ROOT; 4 [hp_X]/150mL CETRARIA ISLANDICA SUBSP. ISLANDICA; 6 [hp_X]/150mL COCHINEAL; 8 [hp_X]/150mL COPPER; 1 [hp_X]/150mL DROSERA ROTUNDIFOLIA; 1 [hp_X]/150mL ECHINACEA ANGUSTIFOLIA; 4 [hp_X]/150mL LOBARIA PULMONARIA; 1 [hp_X]/150mL PLANTAGO MAJOR; 1 [hp_X]/150mL THYME
  • Administration Route(s): ORAL
  • Dosage Form(s): SOLUTION/ DROPS
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Copper [CS]; Copper-containing Intrauterine Device [EPC]; Decreased Embryonic Implantation [PE]; Decreased Sperm Motility [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Inhibit Ovum Fertilization [PE]; Non-Standardized Food Allergenic Extract [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Guna spa
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:5/27/2010

Package Information

No. Package Code Package Description Billing Unit
117089-453-241 BOTTLE in 1 BOX (17089-453-24) / 150 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC17089-453The 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 NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEGUNA-COUGHThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEALTHAEA OFFICINALIS LEAF - ANTIMONY POTASSIUM TARTRATE - BRYONIA ALBA ROOT - CETRARIA ISLANDICA SUBSP. ISLANDICA - COCHINEAL - COPPER - DROSERA ROTUNDIFOLIA - ECHINACEA ANGUSTIFOLIA - GARDEN THYME - LOBARIA PULMONARIA - PLANTAGO MAJOR -The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/27/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED HOMEOPATHICProduct 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.
LABELER NAMEGuna spaName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEALTHAEA OFFICINALIS LEAF; ANTIMONY POTASSIUM TARTRATE; BRYONIA ALBA ROOT; CETRARIA ISLANDICA SUBSP. ISLANDICA; COCHINEAL; COPPER; DROSERA ROTUNDIFOLIA; ECHINACEA ANGUSTIFOLIA; LOBARIA PULMONARIA; PLANTAGO MAJOR; THYMEAn 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.
ACTIVE NUMERATOR STRENGTH1; 8; 6; 4; 6; 8; 1; 1; 4; 1; 1 
ACTIVE INGRED UNIT[hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL; [hp_X]/150mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC] 

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This page was last updated on: 1/16/2026

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