17089-451 NDC - GUNA-SINUS NOSE (ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -)

Drug Information

Product NDC: 17089-451
Proprietary Name: GUNA-SINUS NOSE
Non Proprietary Name: ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -
Active Ingredient(s): 2 [hp_X]/30mL ALTHAEA OFFICINALIS LEAF; 2 [hp_X]/30mL ASCORBIC ACID; 1 [hp_X]/30mL BLACK CURRANT; 8 [hp_X]/30mL CALCIUM SULFIDE; 3 [hp_X]/30mL COPPER; 3 [hp_X]/30mL ECHINACEA ANGUSTIFOLIA; 8 [hp_X]/30mL GOLDENSEAL; 30 [hp_X]/30mL LACHESIS MUTA VENOM; 2 [hp_X]/30mL LOBARIA PULMONARIA; 3 [hp_X]/30mL MANGANESE; 8 [hp_X]/30mL MERCURIC SULFIDE; 8 [hp_X]/30mL ONION; 2 [hp_X]/30mL PLANTAGO MAJOR; 8 [hp_X]/30mL POTASSIUM DICHROMATE; 8 [hp_X]/30mL PULSATILLA VULGARIS; 8 [hp_X]/30mL SILICON DIOXIDE; 10 [hp_X]/30mL SILVER NITRATE; 30 [hp_X]/30mL SINUSITISINUM; 12 [hp_X]/30mL SUS SCROFA NASAL MUCOSA; 12 [hp_X]/30mL SUS SCROFA THYMUS; 30 [hp_X]/30mL SUS SCROFA URINARY BLADDER
Administration Route(s): NASAL
Dosage Form(s): SPRAY
Pharmacy Class(es): Allergens [CS]; Ascorbic Acid [CS]; Cell-mediated Immunity [PE]; Copper [CS]; Copper-containing Intrauterine Device [EPC]; Decreased Embryonic Implantation [PE]; Decreased Sperm Motility [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Inhibit Ovum Fertilization [PE]; Non-Standardized Food Allergenic Extract [EPC]; Vegetable Proteins [CS]; 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	17089-451-23	1 BOTTLE, SPRAY in 1 BOX (17089-451-23) / 30 mL in 1 BOTTLE, SPRAY

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	17089-451	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-SINUS NOSE	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	ALTHAEA OFFICINALIS LEAF - ASCORBIC ACID - BLACK CURRANT - CALCIUM SULFIDE - COPPER - ECHINACEA ANGUSTIFOLIA - GOLDENSEAL - LACHESIS MUTA VENOM - LOBARIA PULMONARIA - MANGANESE - MERCURIC SULFIDE - ONION - PLANTAGO MAJOR - POTASSIUM CARBONATE - PULSATILLA VULGARIS - SILICON DIOXIDE - SILVER NITRATE - SINUSITISINUM - SUS SCROFA NASAL MUCOSA - SUS SCROFA THYMUS - SUS SCROFA URINARY BLADDER -	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	SPRAY	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	NASAL	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	ALTHAEA OFFICINALIS LEAF; ASCORBIC ACID; BLACK CURRANT; CALCIUM SULFIDE; COPPER; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; LACHESIS MUTA VENOM; LOBARIA PULMONARIA; MANGANESE; MERCURIC SULFIDE; ONION; PLANTAGO MAJOR; POTASSIUM DICHROMATE; PULSATILLA VULGARIS; SILICON DIOXIDE; SILVER NITRATE; SINUSITISINUM; SUS SCROFA NASAL MUCOSA; SUS SCROFA THYMUS; SUS SCROFA URINARY BLADDER	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	2; 2; 1; 8; 3; 3; 8; 30; 2; 3; 8; 8; 2; 8; 8; 8; 10; 30; 12; 12; 30
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; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
PHARM CLASSES	Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS], Vitamin C [EPC]

Drug Information

Labeler Information

Package Information

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