17089-461 NDC - GUNA ALLERGY (ADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA -)

Drug Information

Product NDC: 17089-461
Proprietary Name: GUNA ALLERGY
Non Proprietary Name: Adrenalinum - allium cepa - ammonium carbonicum - apis mellifica - argentum nitricum - arsenicum album - cuprum aceticum - galphimia glauca - glandula suprarenalis suis - histaminum hydrochloricum - luffa operculata - matricaria chamomilla - mucosa nasalis suis - natrum muriaticum - sabadilla - scilla maritima -
Active Ingredient(s): 12 [hp_X]/30mL AMMONIUM CARBONATE; 200 [hp_X]/30mL APIS MELLIFERA; 12 [hp_X]/30mL ARSENIC TRIOXIDE; 12 [hp_X]/30mL CUPRIC ACETATE; 12 [hp_X]/30mL DRIMIA MARITIMA BULB; 6 [hp_X]/30mL EPINEPHRINE; 6 [hp_X]/30mL GALPHIMIA GLAUCA FLOWERING TOP; 200 [hp_X]/30mL HISTAMINE DIHYDROCHLORIDE; 6 [hp_X]/30mL LUFFA OPERCULATA FRUIT; 3 [hp_X]/30mL MATRICARIA CHAMOMILLA WHOLE; 12 [hp_X]/30mL ONION; 12 [hp_X]/30mL SCHOENOCAULON OFFICINALE SEED; 30 [hp_X]/30mL SILVER NITRATE; 12 [hp_X]/30mL SODIUM CHLORIDE; 6 [hp_X]/30mL SUS SCROFA ADRENAL GLAND; 200 [hp_X]/30mL SUS SCROFA NASAL MUCOSA
Administration Route(s): ORAL
Dosage Form(s): SOLUTION/ DROPS
Pharmacy Class(es): Adrenergic alpha-Agonists [MoA]; Adrenergic beta-Agonists [MoA]; Allergens [CS]; Allergens [CS]; Bee Venoms [CS]; Catecholamine [EPC]; Catecholamines [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Food Allergenic Extract [EPC]; Standardized Insect Venom Allergenic Extract [EPC]; Vegetable Proteins [CS]; alpha-Adrenergic Agonist [EPC]; beta-Adrenergic Agonist [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:	9/24/2020

Package Information

No.	Package Code	Package Description	Billing Unit
1	17089-461-18	1 BOTTLE, DROPPER in 1 BOX (17089-461-18) / 30 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	17089-461	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 Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	GUNA ALLERGY	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Adrenalinum - allium cepa - ammonium carbonicum - apis mellifica - argentum nitricum - arsenicum album - cuprum aceticum - galphimia glauca - glandula suprarenalis suis - histaminum hydrochloricum - luffa operculata - matricaria chamomilla - mucosa nasalis suis - natrum muriaticum - sabadilla - scilla maritima -	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SOLUTION/ DROPS	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	9/24/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
LABELER NAME	Guna spa	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; CUPRIC ACETATE; DRIMIA MARITIMA BULB; EPINEPHRINE; GALPHIMIA GLAUCA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; LUFFA OPERCULATA FRUIT; MATRICARIA CHAMOMILLA WHOLE; ONION; SCHOENOCAULON OFFICINALE SEED; SILVER NITRATE; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; SUS SCROFA NASAL MUCOSA	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.
ACTIVE NUMERATOR STRENGTH	12; 200; 12; 12; 12; 6; 6; 200; 6; 3; 12; 12; 30; 12; 6; 200
ACTIVE INGRED UNIT	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
PHARM CLASSES	Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Bee Venoms [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]

Drug Information

Labeler Information

Package Information

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