57955-2826 NDC - GOUT SYMPTOM FORMULA (AMMONIUM PHOSPHORICUM, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA, URTICA URENS.)

Drug Information

Product NDC: 57955-2826

Proprietary Name: Gout Symptom Formula

Non Proprietary Name: Ammonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens.

Active Ingredient(s):
  • 10 [hp_X]/59mL AMMONIUM PHOSPHATE, DIBASIC;
  • 10 [hp_X]/59mL ATROPA BELLADONNA;
  • 10 [hp_X]/59mL COLCHICUM AUTUMNALE BULB;
  • 10 [hp_X]/59mL FORMIC ACID;
  • 10 [hp_X]/59mL FRAXINUS EXCELSIOR LEAF;
  • 10 [hp_X]/59mL RHODODENDRON TOMENTOSUM LEAFY TWIG;
  • 10 [hp_X]/59mL SODIUM CARBONATE;
  • 10 [hp_X]/59mL STRYCHNOS NUX-VOMICA SEED;
  • 10 [hp_X]/59mL URTICA URENS WHOLE


Administration Route(s): ORAL

Dosage Form(s): LIQUID

Pharmacy Class(es):
  • Allergens [CS];
  • Cell-mediated Immunity [PE];
  • Increased Histamine Release [PE];
  • Increased IgG Production [PE];
  • Non-Standardized Plant Allergenic Extract [EPC];
  • Plant Proteins [CS];
  • Seed Storage Proteins [CS]

Labeler Information

Labeler Name: King Bio Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:6/22/2022

Package Information

No. Package Code Package Description Billing Unit
157955-2826-21 BOTTLE, SPRAY in 1 CARTON (57955-2826-2) / 59 mL in 1 BOTTLE, SPRAY

NDC Record

Field Name Field Value Definition
PRODUCT NDC57955-2826The 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 NAMEGout Symptom FormulaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAmmonium phosphoricum, Belladonna, Colchicum autumnale, Formicum acidum, Fraxinus excelsior, Ledum palustre, Natrum carbonicum, Nux vomica, Urtica urens.The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe 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 DATE6/22/2022This 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 NAMEKing Bio Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAMMONIUM PHOSPHATE, DIBASIC; ATROPA BELLADONNA; COLCHICUM AUTUMNALE BULB; FORMIC ACID; FRAXINUS EXCELSIOR LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEED; URTICA URENS WHOLEAn 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 STRENGTH10; 10; 10; 10; 10; 10; 10; 10; 10 
ACTIVE INGRED UNIT[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS] 

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This page was last updated on: 2/1/2023