FDA.reportPublic FDA data

Endoplex F

Product NDC
43857-0417
11-digit product format
438570417
Labeler code
43857
Product ID
43857-0417_83714b9e-4b13-436f-b1c2-f4575cbb81d2
Type
HUMAN OTC DRUG
Nonproprietary name
Cimicifuga Racemosa, Fucus Vesiculosus, Glycyrrhiza Glabra, Xanthoxylum Fraxineum, Adrenalinum, Cerebrum Suis, Hypophysis Suis, Hypothalamus (Suis), Oophorinum (Suis), Pineal (Suis), Thyroidinum (Suis), Pulsatilla (Vulgaris), Sepia
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2016-09-29
Substance
BLACK COHOSH; FUCUS VESICULOSUS; GLYCYRRHIZA GLABRA; ZANTHOXYLUM AMERICANUM BARK; EPINEPHRINE; SUS SCROFA CEREBRUM; SUS SCROFA PITUITARY GLAND, POSTERIOR; SUS SCROFA HYPOTHALAMUS; SUS SCROFA OVARY; SUS SCROFA PINEAL GLAND; THYROID; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE
Active strength
3; 3; 3; 3; 8; 8; 8; 8; 8; 8; 8; 12; 12 [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
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [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], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Endoplex F
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BLACK COHOSH3 [hp_X]/mL
FUCUS VESICULOSUS3 [hp_X]/mL
GLYCYRRHIZA GLABRA3 [hp_X]/mL
ZANTHOXYLUM AMERICANUM BARK3 [hp_X]/mL
EPINEPHRINE8 [hp_X]/mL
SUS SCROFA CEREBRUM8 [hp_X]/mL
SUS SCROFA PITUITARY GLAND, POSTERIOR8 [hp_X]/mL
SUS SCROFA HYPOTHALAMUS8 [hp_X]/mL
SUS SCROFA OVARY8 [hp_X]/mL
SUS SCROFA PINEAL GLAND8 [hp_X]/mL
THYROID8 [hp_X]/mL
PULSATILLA VULGARIS WHOLE12 [hp_X]/mL
SEPIA OFFICINALIS JUICE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 13 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K73E24S6X9Internal UNII lookup
535G2ABX9MInternal UNII lookup
2788Z9758HInternal UNII lookup
A4KL1HMZ7TInternal UNII lookup
YKH834O4BHInternal UNII lookup
4GB5DQR532Internal UNII lookup
E8S87O660TInternal UNII lookup
N6R0856Z79Internal UNII lookup
S7YTV04R8OInternal UNII lookup
050QZ2EDK7Internal UNII lookup
6RV024OAUQInternal UNII lookup
I76KB35JEVInternal UNII lookup
QDL83WN8C2Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bfe6d42a-a3e5-44b3-ab8f-b08ad4e2b66fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0417-1Endoplex F30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0417ENDOPLEX F (CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, GLYCYRRHIZA GLABRA, XANTHOXYLUM FRAXINEUM, ADRENALINUM, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS (SUIS), OOPHORINUM (SUIS), PINEAL (SUIS), THYROIDINUM (SUIS), PULSATILLA (VULGARIS), SEPIA) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, Legacy NDC, 1 package rows20160930_bfe6d42a-a3e5-44b3-ab8f-b08ad4e2b66f.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
Endoplex FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, GLYCYRRHIZA GLABRA, XANTHOXYLUM FRAXINEUM, ADRENALINUM, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS (SUIS), OOPHORINUM (SUIS), PINEAL (SUIS), THYROIDINUM (SUIS), PULSATILLA (VULGARIS), SEPIABioActive Nutritional, Inc.bfe6d42a-a3e5-44b3-ab8f-b08ad4e2b66f2026-03-30WarningsExact identifier
ndc (product): 43857-0417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0417-14385704170130 mL in 1 BOTTLE, DROPPER (43857-0417-1) 30 ml2016-09-290000-00-00NoNoCurrent