FDA.reportPublic FDA data

Leaky Gut Formula

Product NDC
43742-2019
11-digit product format
437422019
Labeler code
43742
Product ID
43742-2019_eba4ef3d-e1b6-4c9b-a504-e58fa82f605a
Type
HUMAN OTC DRUG
Nonproprietary name
Alfalfa, Glycyrrhiza Glabra, Astacus Fluviatilis, Berberis Aquifolium, Lac Defloratum, Natrum Carbonicum, Saccharum Officinale, Aloe, Fel Tauri, Pancreas Suis, Pancreatinum, Fragaria Vesca, Antimonium Crudum, Carbo Vegetabilis, Euphorbium Officinarum, Lycopodium Clavatum, Magnesia Carbonica, Zincum Metallicum, Colibacillinum Cum Natrum Muriaticum, Proteus (Vulgaris)
Dosage form
LIQUID
Route
ORAL
Labeler
Deseret Biologicals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-06-18
Marketing end
2028-05-31
Substance
MEDICAGO SATIVA WHOLE; GLYCYRRHIZA GLABRA; ASTACUS ASTACUS; BERBERIS AQUIFOLIUM ROOT BARK; SKIM MILK; SODIUM CARBONATE; SUCROSE; ALOE; BOS TAURUS BILE; SUS SCROFA PANCREAS; PANCRELIPASE; FRAGARIA VESCA FRUIT; ANTIMONY TRISULFIDE; ACTIVATED CHARCOAL; EUPHORBIA RESINIFERA RESIN; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; ZINC; ESCHERICHIA COLI; PROTEUS VULGARIS
Active strength
3; 3; 6; 6; 6; 6; 6; 7; 8; 8; 8; 9; 12; 12; 12; 12; 12; 12; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Leaky Gut Formula

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEDICAGO SATIVA WHOLE3 [hp_X]/mL
GLYCYRRHIZA GLABRA3 [hp_X]/mL
ASTACUS ASTACUS6 [hp_X]/mL
BERBERIS AQUIFOLIUM ROOT BARK6 [hp_X]/mL
SKIM MILK6 [hp_X]/mL
SODIUM CARBONATE6 [hp_X]/mL
SUCROSE6 [hp_X]/mL
ALOE7 [hp_X]/mL
BOS TAURUS BILE8 [hp_X]/mL
SUS SCROFA PANCREAS8 [hp_X]/mL
PANCRELIPASE8 [hp_X]/mL
FRAGARIA VESCA FRUIT9 [hp_X]/mL
ANTIMONY TRISULFIDE12 [hp_X]/mL
ACTIVATED CHARCOAL12 [hp_X]/mL
EUPHORBIA RESINIFERA RESIN12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
MAGNESIUM CARBONATE12 [hp_X]/mL
ZINC12 [hp_X]/mL
ESCHERICHIA COLI15 [hp_X]/mL
PROTEUS VULGARIS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DJO934BRBDInternal UNII lookup
2788Z9758HInternal UNII lookup
V0551986XQInternal UNII lookup
VZJ9F3C3SBInternal UNII lookup
6A001Y4M5AInternal UNII lookup
45P3261C7TInternal UNII lookup
C151H8M554Internal UNII lookup
V5VD430YW9Internal UNII lookup
ET3651ZLOUInternal UNII lookup
9Y3J3362RYInternal UNII lookup
FQ3DRG0N5KInternal UNII lookup
CG6IX3GCMUInternal UNII lookup
F79059A38UInternal UNII lookup
2P3VWU3H10Internal UNII lookup
1TI1O9028KInternal UNII lookup
C88X29Y479Internal UNII lookup
0E53J927NAInternal UNII lookup
J41CSQ7QDSInternal UNII lookup
514B9K0L10Internal UNII lookup
11T9HCO30OInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8679e9ab-8610-47f1-be0e-66897f99881dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-2019-1Leaky Gut Formula30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-2019LEAKY GUT FORMULA (ALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)) LIQUID [DESERET BIOLOGICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20230715_8679e9ab-8610-47f1-be0e-66897f99881d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
ndc (product): 43742-2019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43742-2019-14374220190130 mL in 1 BOTTLE, DROPPER (43742-2019-1) 30 ml2021-06-182028-05-31NoNoCurrent