17089-416 NDC - GUNA-MATRIX (ASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - PHENYLALANINE - PRASTERONE - PROLACTIN - RANCID BEEF - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - THUJA OCCIDENTALIS TWIG - TYROSINE -)

Drug Information

Product NDC: 17089-416
Proprietary Name: GUNA-MATRIX
Non Proprietary Name: ASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - PHENYLALANINE - PRASTERONE - PROLACTIN - RANCID BEEF - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - THUJA OCCIDENTALIS TWIG - TYROSINE -
Active Ingredient(s): 4 [hp_X]/30mL ASCORBIC ACID; 6 [hp_X]/30mL DODECAHYDROXYCYCLOHEXANE DIHYDRATE; 4 [hp_X]/30mL FUCUS VESICULOSUS; 4 [hp_X]/30mL HISTIDINE MONOHYDROCHLORIDE; 4 [hp_C]/30mL HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); 6 [hp_X]/30mL HYALURONIDASE; 4 [hp_X]/30mL LACTIC ACID, DL-; 6 [hp_X]/30mL MALIC ACID; 6 [hp_X]/30mL NADIDE; 4 [hp_X]/30mL PHENYLALANINE; 6 [hp_X]/30mL PRASTERONE; 6 [hp_X]/30mL PROLACTIN; 12 [hp_X]/30mL RANCID BEEF; 6 [hp_X]/30mL SODIUM DIETHYL OXALACETATE; 6 [hp_X]/30mL SODIUM PYRUVATE; 12 [hp_X]/30mL SODIUM SULFATE; 6 [hp_X]/30mL SUS SCROFA CONJUNCTIVA; 6 [hp_X]/30mL SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; 12 [hp_X]/30mL THUJA OCCIDENTALIS LEAFY TWIG; 4 [hp_X]/30mL TYROSINE
Administration Route(s): ORAL
Dosage Form(s): SOLUTION/ DROPS
Pharmacy Class(es): Ascorbic Acid [CS]; Endoglycosidase [EPC]; Glycoside Hydrolases [CS]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Vitamin C [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
1	17089-416-18	1 BOTTLE, DROPPER in 1 BOX (17089-416-18) / 30 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	17089-416	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-MATRIX	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	ASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - PHENYLALANINE - PRASTERONE - PROLACTIN - RANCID BEEF - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - THUJA OCCIDENTALIS TWIG - TYROSINE -	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	5/27/2010	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	ASCORBIC ACID; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; FUCUS VESICULOSUS; HISTIDINE MONOHYDROCHLORIDE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); HYALURONIDASE; LACTIC ACID, DL-; MALIC ACID; NADIDE; PHENYLALANINE; PRASTERONE; PROLACTIN; RANCID BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SUS SCROFA CONJUNCTIVA; SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE	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; 6; 4; 4; 4; 6; 4; 6; 6; 4; 6; 6; 12; 6; 6; 12; 6; 6; 12; 4
ACTIVE INGRED UNIT	[hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/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	Ascorbic Acid [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Vitamin C [EPC]

Drug Information

Labeler Information

Package Information

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