85631-004 NDC - COMPOUND OYSTER PEPTIDE

Drug Information

  • Product NDC: 85631-004
  • Proprietary Name: COMPOUND OYSTER PEPTIDE
  • Non Proprietary Name: COMPOUND OYSTER PEPTIDE
  • Active Ingredient(s): 180 mg/1.2g ASIAN GINSENG; 180 mg/1.2g CORNUS OFFICINALIS WHOLE; 96 mg/1.2g DIOSCOREA CAYENENSIS TUBER; 24 mg/1.2g LICORICE; 270 mg/1.2g LYCIUM CHINENSE FRUIT; 12 mg/1.2g OYSTER, UNSPECIFIED; 72 mg/1.2g PHYLLOLOBIUM CHINENSE SEED; 90 mg/1.2g POLYGONATUM SIBIRICUM WHOLE; .24 mg/1.2g RIBOFLAVIN; 120 mg/1.2g SEA CUCUMBER, UNSPECIFIED; 30 mg/1.2g TAURINE; .6 mg/1.2g THIAMINE; 72 mg/1.2g WHITE MULBERRY; 5.16 mg/1.2g ZINC LACTATE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE
  • Pharmacy Class(es): Allergens [CS]; Cell-mediated Immunity [PE]; Copper Absorption Inhibitor [EPC]; Decreased Copper Ion Absorption [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Non-Standardized Food Allergenic Extract [EPC]; Shellfish Proteins [EXT]

Labeler Information

Field Name Field Value
Labeler Name: Bispit Canada Ltd.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED HOMEOPATHIC
Start Marketing Date:8/3/2025

Package Information

No. Package Code Package Description Billing Unit
185631-004-0160 CAPSULE in 1 BOTTLE (85631-004-01) / 1.2 g in 1 CAPSULE

NDC Record

Field Name Field Value Definition
PRODUCT NDC85631-004The 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 NAMECOMPOUND OYSTER PEPTIDEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECOMPOUND OYSTER PEPTIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe 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 DATE8/3/2025This 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 NAMEBispit Canada Ltd.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEASIAN GINSENG; CORNUS OFFICINALIS WHOLE; DIOSCOREA CAYENENSIS TUBER; LICORICE; LYCIUM CHINENSE FRUIT; OYSTER, UNSPECIFIED; PHYLLOLOBIUM CHINENSE SEED; POLYGONATUM SIBIRICUM WHOLE; RIBOFLAVIN; SEA CUCUMBER, UNSPECIFIED; TAURINE; THIAMINE; WHITE MULBERRY; ZINC LACTATEAn 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 STRENGTH180; 180; 96; 24; 270; 12; 72; 90; .24; 120; 30; .6; 72; 5.16 
ACTIVE INGRED UNITmg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g; mg/1.2g 
PHARM CLASSESAllergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Shellfish Proteins [EXT] 

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This page was last updated on: 9/5/2025

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