MedPath

COMPOUND OYSTER PEPTIDE

85631-004-01

Approved
Approval ID

3b778dc1-d1ac-1415-e063-6394a90aeb39

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 3, 2025

Manufacturers
FDA

Bispit Canada Ltd.

DUNS: 243332192

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

COMPOUND OYSTER PEPTIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85631-004
Product Classification
G
Generic Name
COMPOUND OYSTER PEPTIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2025
FDA Product Classification

INGREDIENTS (15)

LYCIUM CHINENSE FRUITActive
Quantity: 270 mg in 1.2 g
Code: TG711Q7A1Q
Classification: ACTIB
ASIAN GINSENGActive
Quantity: 180 mg in 1.2 g
Code: CUQ3A77YXI
Classification: ACTIB
LICORICEActive
Quantity: 24 mg in 1.2 g
Code: 61ZBX54883
Classification: ACTIB
POLYGONATUM SIBIRICUM WHOLEActive
Quantity: 90 mg in 1.2 g
Code: PRE2H4N127
Classification: ACTIB
PHYLLOLOBIUM CHINENSE SEEDActive
Quantity: 72 mg in 1.2 g
Code: 59H16CDI5E
Classification: ACTIB
RIBOFLAVINActive
Quantity: 0.24 mg in 1.2 g
Code: TLM2976OFR
Classification: ACTIB
ZINC LACTATEActive
Quantity: 5.16 mg in 1.2 g
Code: 2GXR25858Y
Classification: ACTIB
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
TAURINEActive
Quantity: 30 mg in 1.2 g
Code: 1EQV5MLY3D
Classification: ACTIB
THIAMINEActive
Quantity: 0.6 mg in 1.2 g
Code: X66NSO3N35
Classification: ACTIB
CORNUS OFFICINALIS WHOLEActive
Quantity: 180 mg in 1.2 g
Code: CXC44F678T
Classification: ACTIB
SEA CUCUMBER, UNSPECIFIEDActive
Quantity: 120 mg in 1.2 g
Code: LUE8BK8H5Q
Classification: ACTIB
DIOSCOREA CAYENENSIS TUBERActive
Quantity: 96 mg in 1.2 g
Code: NO8P209GIH
Classification: ACTIB
WHITE MULBERRYActive
Quantity: 72 mg in 1.2 g
Code: MN25R0HH5A
Classification: ACTIB
OYSTER, UNSPECIFIEDActive
Quantity: 12 mg in 1.2 g
Code: S614XWR17V
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/3/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/3/2025

Thisproductisuable for men.Long em use helpsnouish the kidneys antvila energyenhancephyskcal igoimprowve thequalty of sexual le,imprvemornimg erecions and hardnes,andeeve postcoita
fatigue. This product ispurely derived from botanical extracls, making it suitable for long-term use withno reported adverse side effects

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/3/2025

ASIAN GINSENG
LYCIUM CHINENSE FRUIT
POLYGONATUM SIBIRICUM WHOLE
CORNUS OFFICINALIS WHOLE
SEA CUCUMBER, UNSPECIFIED
PHYLLOLOBIUM CHINENSE SEED
WHITE MULBERRY
DIOSCOREA CAYENENSIS TUBER
1EQV5MLY3D
LICORICE
OYSTER
ZINC LACTATE
THIAMINE
RIBOFLAVIN

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/3/2025

lmprove Physical EnergyEnhance The Quality Of Sexual Life

WARNINGS SECTION

LOINC: 34071-1Updated: 8/3/2025

Not suitable for individuals under 18years of age

Do not use if you have a seafood allergy.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/3/2025

Keep out of reach of children.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/3/2025

Do not use if you have a seafood allergy

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/3/2025

This productisuatle for men.Longlem use helps nourish the kidneys andal energy enhance physical vigorimprove thequalty of sexualfe,improvemornimg erecions and hardnes,andeeve postcoila
fatigue. This product ispurely derived from botanical extracts,making it suitable for long-term use withno reported adverse side effects.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Dosage:2-4 tablets per day

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/3/2025

CALCIUM CARBONATE

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