57955-9971 NDC - LOWER GI AND PROBIOTIC RESTORATION (AETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.)

Drug Information

  • Product NDC: 57955-9971
  • Proprietary Name: Lower GI and Probiotic Restoration
  • Non Proprietary Name: Aethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltatum, Sepia and Silicea.
  • Active Ingredient(s): 10 [hp_X]/59mL ACTIVATED CHARCOAL; 10 [hp_X]/59mL AETHUSA CYNAPIUM WHOLE; 10 [hp_X]/59mL BAPTISIA TINCTORIA ROOT; 10 [hp_X]/59mL CAPSICUM; 10 [hp_X]/59mL CINCHONA OFFICINALIS BARK; 10 [hp_X]/59mL CITRULLUS COLOCYNTHIS FRUIT PULP; 10 [hp_X]/59mL COLLINSONIA CANADENSIS ROOT; 10 [hp_X]/59mL COW MILK; 10 [hp_X]/59mL GAMBOGE; 10 [hp_X]/59mL GARLIC; 10 [hp_X]/59mL GRATIOLA OFFICINALIS WHOLE; 10 [hp_X]/59mL LACTIC ACID, DL-; 10 [hp_X]/59mL MATRICARIA CHAMOMILLA WHOLE; 10 [hp_X]/59mL PODOPHYLLUM; 10 [hp_X]/59mL RUEHSSIA CUNDURANGO BARK; 10 [hp_X]/59mL SEPIA OFFICINALIS JUICE; 10 [hp_X]/59mL SILICON DIOXIDE; 10 [hp_X]/59mL SODIUM CARBONATE; 10 [hp_X]/59mL STRYCHNOS NUX-VOMICA SEED
  • Administration Route(s): ORAL
  • Dosage Form(s): LIQUID
  • Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Dietary Proteins [CS]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Milk Proteins [CS]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Vegetable Proteins [CS]

Labeler Information

Field Name Field Value
Labeler Name: King Bio Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:3/13/2026

Package Information

No. Package Code Package Description Billing Unit
157955-9971-259 mL in 1 BOTTLE, SPRAY (57955-9971-2)

NDC Record

Field Name Field Value Definition
PRODUCT NDC57955-9971The 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 NAMELower GI and Probiotic RestorationThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAethusa cynapium, Allium sativum, Baptisia tinctoria, Capsicum annuum, Carbo vegetabilis, Chamomilla, Cinchona officinalis, Collinsonia canadensis, Colocynthis, Condurango, Gambogia, Gratiola officinalis, Lac vaccinum, Lacticum acidum, Natrum carbonicum, Nux vomica, Podophyllum peltatum, Sepia and Silicea.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 DATE3/13/2026This 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 NAMEACTIVATED CHARCOAL; AETHUSA CYNAPIUM WHOLE; BAPTISIA TINCTORIA ROOT; CAPSICUM; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; COLLINSONIA CANADENSIS ROOT; COW MILK; GAMBOGE; GARLIC; GRATIOLA OFFICINALIS WHOLE; LACTIC ACID, DL-; MATRICARIA CHAMOMILLA WHOLE; PODOPHYLLUM; RUEHSSIA CUNDURANGO BARK; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CARBONATE; STRYCHNOS NUX-VOMICA SEEDAn 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; 10; 10; 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; [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; [hp_X]/59mL 
PHARM CLASSESAllergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS] 

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This page was last updated on: 4/14/2026

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