57955-9977 NDC - UPPER GI AND ENZYME RESTORATION (ACETICUM ACIDUM, AGARICUS MUSCARIUS, ALOE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINCHONA OFFICINALIS, GRAPHITES, IPECACUANHA, LAC DEFLORATUM, MENTHA PIPERITA, NUX VOMICA, SECALE CORNUTUM, TANACETUM VULGARE, TEUCRIUM MARUM AND ZINGIBER OFFICINALE.)

Drug Information

Product NDC: 57955-9977
Proprietary Name: Upper Gi and Enzyme Restoration
Non Proprietary Name: Aceticum acidum, Agaricus muscarius, Aloe, Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Carduus marianus, Chelidonium majus, Chenopodium anthelminticum, Cinchona officinalis, Graphites, Ipecacuanha, Lac defloratum, Mentha piperita, Nux vomica, Secale cornutum, Tanacetum vulgare, Teucrium marum and Zingiber officinale.
Active Ingredient(s): 10 [hp_X]/59mL ACETIC ACID; 10 [hp_X]/59mL ACTIVATED CHARCOAL; 10 [hp_X]/59mL ALOE; 10 [hp_X]/59mL AMANITA MUSCARIA FRUITING BODY; 10 [hp_X]/59mL ANTIMONY TRISULFIDE; 10 [hp_X]/59mL CHELIDONIUM MAJUS WHOLE; 10 [hp_X]/59mL CINCHONA OFFICINALIS BARK; 10 [hp_X]/59mL CLAVICEPS PURPUREA SCLEROTIUM; 10 [hp_X]/59mL DYSPHANIA AMBROSIOIDES WHOLE; 10 [hp_X]/59mL GINGER; 10 [hp_X]/59mL GRAPHITE; 10 [hp_X]/59mL IPECAC; 10 [hp_X]/59mL MENTHA X PIPERITA WHOLE; 10 [hp_X]/59mL MILK THISTLE; 10 [hp_X]/59mL SILVER NITRATE; 10 [hp_X]/59mL SKIM MILK; 10 [hp_X]/59mL STRYCHNOS NUX-VOMICA SEED; 10 [hp_X]/59mL TANACETUM VULGARE TOP; 10 [hp_X]/59mL TEUCRIUM MARUM WHOLE
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Allergens [CS]; Allergens [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Food Additives [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Plant Proteins [CS]; Plant Proteins [CS]; Seed Storage 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:	3/15/2026

Package Information

No.	Package Code	Package Description	Billing Unit
1	57955-9977-2	59 mL in 1 BOTTLE, SPRAY (57955-9977-2)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	57955-9977	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	Upper Gi and Enzyme Restoration	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	Aceticum acidum, Agaricus muscarius, Aloe, Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Carduus marianus, Chelidonium majus, Chenopodium anthelminticum, Cinchona officinalis, Graphites, Ipecacuanha, Lac defloratum, Mentha piperita, Nux vomica, Secale cornutum, Tanacetum vulgare, Teucrium marum and Zingiber officinale.	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	LIQUID	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	3/15/2026	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	King Bio Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ACETIC ACID; ACTIVATED CHARCOAL; ALOE; AMANITA MUSCARIA FRUITING BODY; ANTIMONY TRISULFIDE; CHELIDONIUM MAJUS WHOLE; CINCHONA OFFICINALIS BARK; CLAVICEPS PURPUREA SCLEROTIUM; DYSPHANIA AMBROSIOIDES WHOLE; GINGER; GRAPHITE; IPECAC; MENTHA X PIPERITA WHOLE; MILK THISTLE; SILVER NITRATE; SKIM MILK; STRYCHNOS NUX-VOMICA SEED; TANACETUM VULGARE TOP; TEUCRIUM MARUM WHOLE	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	10; 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 CLASSES	Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]

Drug Information

Labeler Information

Package Information

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