17089-500 NDC - GUNA HEALTHY BRAIN (CITRULLUS COLOCYNTHIS FRUIT PULP - UBIDECARENONE - SUS SCRIFA ADRENAL GLAND - SUS SCROFA PLACENTA - SELENIUM - THUJA OCCIDENTALIS LEAFY TWIG - CONIUM MACULATUM FLOWERING TOP - SUS SCROFA EMBRYO - ACONITUM NAPELLUS - ALOE - BARIUM OXALOSUCCINATE - SUS SCROFA CEREBRUM - ARNICA MONTANA - SUS SCROFA HYPOTHALAMUS -)

Drug Information

Product NDC: 17089-500
Proprietary Name: GUNA HEALTHY BRAIN
Non Proprietary Name: Citrullus colocynthis fruit pulp - ubidecarenone - sus scrifa adrenal gland - sus scrofa placenta - selenium - thuja occidentalis leafy twig - conium maculatum flowering top - sus scrofa embryo - aconitum napellus - aloe - barium oxalosuccinate - sus scrofa cerebrum - arnica montana - sus scrofa hypothalamus -
Active Ingredient(s): 4 [hp_X]/30mL ACONITUM NAPELLUS; 4 [hp_X]/30mL ALOE; 3 [hp_X]/30mL ARNICA MONTANA; 6 [hp_X]/30mL BARIUM OXALOSUCCINATE; 4 [hp_X]/30mL CITRULLUS COLOCYNTHIS FRUIT PULP; 4 [hp_X]/30mL CONIUM MACULATUM FLOWERING TOP; 6 [hp_X]/30mL SELENIUM; 6 [hp_X]/30mL SUS SCROFA ADRENAL GLAND; 6 [hp_X]/30mL SUS SCROFA CEREBRUM; 6 [hp_X]/30mL SUS SCROFA EMBRYO; 6 [hp_X]/30mL SUS SCROFA HYPOTHALAMUS; 6 [hp_X]/30mL SUS SCROFA PLACENTA; 8 [hp_X]/30mL THUJA OCCIDENTALIS LEAFY TWIG; 5 [hp_X]/30mL UBIDECARENONE
Administration Route(s): ORAL
Dosage Form(s): SOLUTION/ DROPS

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:	2/17/2021

Package Information

No.	Package Code	Package Description	Billing Unit
1	17089-500-18	1 BOTTLE, DROPPER in 1 BOX (17089-500-18) / 30 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	17089-500	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 HEALTHY BRAIN	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	Citrullus colocynthis fruit pulp - ubidecarenone - sus scrifa adrenal gland - sus scrofa placenta - selenium - thuja occidentalis leafy twig - conium maculatum flowering top - sus scrofa embryo - aconitum napellus - aloe - barium oxalosuccinate - sus scrofa cerebrum - arnica montana - sus scrofa hypothalamus -	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	2/17/2021	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	ACONITUM NAPELLUS; ALOE; ARNICA MONTANA; BARIUM OXALOSUCCINATE; CITRULLUS COLOCYNTHIS FRUIT PULP; CONIUM MACULATUM FLOWERING TOP; SELENIUM; SUS SCROFA ADRENAL GLAND; SUS SCROFA CEREBRUM; SUS SCROFA EMBRYO; SUS SCROFA HYPOTHALAMUS; SUS SCROFA PLACENTA; THUJA OCCIDENTALIS LEAFY TWIG; UBIDECARENONE	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	4; 4; 3; 6; 4; 4; 6; 6; 6; 6; 6; 6; 8; 5
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

Drug Information

Labeler Information

Package Information

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