FDA.reportPublic FDA data

COMPOUND OYSTER PEPTIDE

Product NDC
85631-004
11-digit product format
856310004
Labeler code
85631
Product ID
85631-004_3b778dc1-d1ad-1415-e063-6394a90aeb39
Type
HUMAN OTC DRUG
Nonproprietary name
COMPOUND OYSTER PEPTIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Bispit Canada Ltd.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-08-03
Substance
ASIAN 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 LACTATE
Active strength
180; 180; 96; 24; 270; 12; 72; 90; .24; 120; 30; .6; 72; 5.16 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; mg/1.2g
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COMPOUND OYSTER PEPTIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASIAN GINSENG180 mg/1.2g
CORNUS OFFICINALIS WHOLE180 mg/1.2g
DIOSCOREA CAYENENSIS TUBER96 mg/1.2g
LICORICE24 mg/1.2g
LYCIUM CHINENSE FRUIT270 mg/1.2g
OYSTER, UNSPECIFIED12 mg/1.2g
PHYLLOLOBIUM CHINENSE SEED72 mg/1.2g
POLYGONATUM SIBIRICUM WHOLE90 mg/1.2g
RIBOFLAVIN.24 mg/1.2g
SEA CUCUMBER, UNSPECIFIED120 mg/1.2g
TAURINE30 mg/1.2g
THIAMINE.6 mg/1.2g
WHITE MULBERRY72 mg/1.2g
ZINC LACTATE5.16 mg/1.2g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCUQ3A77YXI, CXC44F678T, NO8P209GIH, 61ZBX54883, TG711Q7A1Q, S614XWR17V, 59H16CDI5E, PRE2H4N127, TLM2976OFR, LUE8BK8H5Q, 1EQV5MLY3D, X66NSO3N35, MN25R0HH5A, 2GXR25858Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85631-004-01COMPOUND OYSTER PEPTIDE60 in 1 BOTTLECAPSULE601
85631-004-01COMPOUND OYSTER PEPTIDE1.2 g in 1 CAPSULECAPSULE1.21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85631-004-018563100040160 CAPSULE in 1 BOTTLE (85631-004-01) / 1.2 g in 1 CAPSULE60 capsule2025-08-03NoNoCurrent