FDA.reportPublic FDA data

Endocrine Balancer

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-02-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:02

Label at a glance#

ProductEndocrine Balancer
Active ingredientFUCUS VESICULOSUS, GLYCYRRHIZA GLABRA, SMILAX ORNATA ROOT, SUS SCROFA ADRENAL GLAND, PINUS SYLVESTRIS LEAFY TWIG, THYROID, IODINE
Label structure9 sections

Dosage and administration

 10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Fucus Vesiculosus 3X, Glycyrrhiza Glabra 3X, Sarsaparilla 3X, Glandula Suprarenalis Suis 6X, Pinus Sylvestris 6X, Thyroidinum (Suis) 8X, Iodium 12X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of nervous exhaustion, mentally sluggish, easily fatigued, weak pulse, cold hands and feet and muscular exhaustion.

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

 10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

 Demineralized Water, 25% Ethanol.

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

 For temporary relief of nervous exhaustion, mentally sluggish, easily fatigues, weak pulse, cold hands and feet and muscular exhaustion.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

ENDOCRINE

BALANCER

HOMEOPATHIC

1 FL OZ (30 ml)

Endocrine BalancerEndocrine Balancer

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0024-12024-02-08C16284748780-19d75b9d0-6220-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0024-12020-01-31C16284748780-19d75b9d0-6220-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0024-1Endocrine Balancer30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0024ENDOCRINE BALANCER (FUCUS VESICULOSUS, GLYCYRRHIZA GLABRA, SARSAPARILLA, GLANDULA SUPRARENALIS SUIS, PINUS SYLVESTRIS, THYROIDINUM (SUIS), IODIUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240209_f77331b4-0bb9-4bad-a7d7-3d2ccbad4dc6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FUCUS VESICULOSUSACTIVE INGREDIENT535G2ABX9M1
GLYCYRRHIZA GLABRAACTIVE INGREDIENT2788Z9758H1
IODINEACTIVE INGREDIENT9679TC07X41
PINUS SYLVESTRIS LEAFY TWIGACTIVE INGREDIENTQ1RGP4UB731
SMILAX REGELII ROOTACTIVE INGREDIENT2H1576D5WG1
SUS SCROFA ADRENAL GLANDACTIVE INGREDIENT398IYQ16YV1
THYROID, PORCINEACTIVE INGREDIENT6RV024OAUQ1
FUCUS VESICULOSUSACTIVE MOIETY535G2ABX9M1
GLYCYRRHIZA GLABRAACTIVE MOIETY2788Z9758H1
IODINEACTIVE MOIETY9679TC07X41
PINUS SYLVESTRIS LEAFY TWIGACTIVE MOIETYQ1RGP4UB731
SMILAX REGELII ROOTACTIVE MOIETY2H1576D5WG1
SUS SCROFA ADRENAL GLANDACTIVE MOIETY398IYQ16YV1
THYROID, PORCINEACTIVE MOIETY6RV024OAUQ1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-002443857-0024-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
FUCUS VESICULOSUS535G2ABX9MACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
PINUS SYLVESTRIS LEAFY TWIGQ1RGP4UB73ACTIB
THYROID6RV024OAUQACTIB
IODINE9679TC07X4ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
Endocrine BalancerFUCUS VESICULOSUS, GLYCYRRHIZA GLABRA, SARSAPARILLA, GLANDULA SUPRARENALIS SUIS, PINUS SYLVESTRIS, THYROIDINUM (SUIS), IODIUMBioActive Nutritional, Inc.f77331b4-0bb9-4bad-a7d7-3d2ccbad4dc62024-02-08WarningsExact identifier
ndc (package): 43857-0024-1
ndc (product): 43857-0024
ndc11 (package): 43857002401
spl id: 79209f7d-aaa1-4236-8242-3c782034148f
spl set id: f77331b4-0bb9-4bad-a7d7-3d2ccbad4dc6

Reported adverse events (FAERS/openFDA)#

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