17089-348 NDC - GUNA-SPASM (ATROPINE SULFATE - BERBERIS VULGARIS ROOT BARK - CHELIDONIUM MAJUS - COBALT - CULTIVATED MUSHROOM - GELSEMIUM SEMPERVIRENS ROOT - INTERLEUKIN-10 - MAGNESIUM - MELATONIN - METENKEFALIN - SUS SCROFA SYMPATHETIC NERVE - SUS SCROFA VAGUS NERVE - WATERMELON - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -)

Drug Information

  • Product NDC: 17089-348
  • Proprietary Name: GUNA-SPASM
  • Non Proprietary Name: atropine sulfate - berberis vulgaris root bark - chelidonium majus - cobalt - cultivated mushroom - gelsemium sempervirens root - interleukin-10 - magnesium - melatonin - metenkefalin - sus scrofa sympathetic nerve - sus scrofa vagus nerve - watermelon - anti-interleukin-1.alpha. immunoglobulin g rabbit -
  • Active Ingredient(s): 4 [hp_C]/30mL ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; 6 [hp_X]/30mL ATROPINE SULFATE; 3 [hp_X]/30mL BERBERIS VULGARIS ROOT BARK; 4 [hp_X]/30mL CHELIDONIUM MAJUS; 4 [hp_X]/30mL COBALT; 4 [hp_X]/30mL CULTIVATED MUSHROOM; 6 [hp_X]/30mL GELSEMIUM SEMPERVIRENS ROOT; 4 [hp_C]/30mL INTERLEUKIN-10; 4 [hp_X]/30mL MAGNESIUM; 4 [hp_C]/30mL MELATONIN; 4 [hp_C]/30mL METENKEFALIN; 200 [hp_X]/30mL SUS SCROFA SYMPATHETIC NERVE; 6 [hp_X]/30mL SUS SCROFA VAGUS NERVE; 4 [hp_X]/30mL WATERMELON
  • Administration Route(s): ORAL
  • Dosage Form(s): SOLUTION/ DROPS
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Anticholinergic [EPC]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cholinergic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]; Cholinergic Muscarinic Antagonists [MoA]; Dietary Proteins [CS]; Dietary Proteins [CS]; Fruit Proteins [EXT]; Fungal Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Standardized Chemical Allergen [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:4/16/2008

Package Information

No. Package Code Package Description Billing Unit
117089-348-181 BOTTLE, DROPPER in 1 BOX (17089-348-18) / 30 mL in 1 BOTTLE, DROPPER

NDC Record

Field Name Field Value Definition
PRODUCT NDC17089-348The 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-SPASMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEatropine sulfate - berberis vulgaris root bark - chelidonium majus - cobalt - cultivated mushroom - gelsemium sempervirens root - interleukin-10 - magnesium - melatonin - metenkefalin - sus scrofa sympathetic nerve - sus scrofa vagus nerve - watermelon - anti-interleukin-1.alpha. immunoglobulin g rabbit -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 DATE4/16/2008This 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 NAMEANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ATROPINE SULFATE; BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; COBALT; CULTIVATED MUSHROOM; GELSEMIUM SEMPERVIRENS ROOT; INTERLEUKIN-10; MAGNESIUM; MELATONIN; METENKEFALIN; SUS SCROFA SYMPATHETIC NERVE; SUS SCROFA VAGUS NERVE; WATERMELONAn 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 STRENGTH4; 6; 3; 4; 4; 4; 6; 4; 4; 4; 4; 200; 6; 4 
ACTIVE INGRED UNIT[hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Anticholinergic [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Standardized Chemical Allergen [EPC] 

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This page was last updated on: 8/8/2025

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