FDA.reportPublic FDA data

ADRENOPLEX

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:36:07

Label at a glance#

ProductADRENOPLEX
Active ingredientCHELIDONIUM MAJUS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE, BOS TAURUS ADRENAL GLAND, SUS SCROFA SPLEEN, MILK THISTLE, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PHOSPHORIC ACID
Label structure9 sections

Indications and uses

For temporary relief of nervous exhaustion, fatigue and forgetfulness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. •  Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Carduus Marianus 12X, Chelidonium Majus 3X, Echinacea 3X, Glandula Suprarenalis Bovine 8X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Phosphoricum Acidum 12X, Spleen 8X.

PURPOSE:

OTC - PURPOSE SECTION

Carduus Marianus - headache,** Chelidonium Majus - drowsiness,** Echinacea - exhaustion,** Glandula Suprarenalis Bovine – adrenal support,** Lycopodium Clavatum - fatigue,** Natrum Muriaticum - headache,** Phosphoricum Acidum – mental debility,** Spleen – fatigue**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of nervous exhaustion, fatigue and forgetfulness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

•  Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ADRENOPLEX

HOMEOPATHIC

1 fl. oz. (30 mL)

ADRENOPLEXADRENOPLEX

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184340568GTIN-13: 0210184340568
EAN-13: 0210184340568
GTIN-12: 210184340568
UPC-A: 210184340568
GTIN storage (14 digits): 00210184340568		BANI41 Adrenoplex 4-21-25.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0331-1ADRENOPLEX30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BOS TAURUS ADRENAL GLANDACTIVE INGREDIENTM2776SWB291
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
MILK THISTLEACTIVE INGREDIENTU946SH95EE1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SUS SCROFA SPLEENACTIVE INGREDIENT92AMN5J79Y1
BOS TAURUS ADRENAL GLANDACTIVE MOIETYM2776SWB291
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN1
CHLORIDE IONACTIVE MOIETYQ32ZN486981
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
MILK THISTLEACTIVE MOIETYU946SH95EE1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
SUS SCROFA SPLEENACTIVE MOIETY92AMN5J79Y1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-033143857-0331-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
BOS TAURUS ADRENAL GLANDM2776SWB29ACTIB
SUS SCROFA SPLEEN92AMN5J79YACTIB
MILK THISTLEU946SH95EEACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
ADRENOPLEXCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GLANDULA SUPRARENALIS BOVINE, SPLEEN (SUIS), CARDUUS MARIANUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUMBioActive Nutritional, Inc.3c53c23e-7654-4e46-acf1-edb0d605ff3b2025-12-18WarningsExact identifier
ndc (package): 43857-0331-1
ndc (product): 43857-0331
ndc11 (package): 43857033101
spl id: ead5525c-942b-48c0-8978-bcda3311b361
spl set id: 3c53c23e-7654-4e46-acf1-edb0d605ff3b

Reported adverse events (FAERS/openFDA)#

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