Spleen

Manufacturer: BioActive Nutritional, Inc. | Apotheca Company
Effective date: 2025-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 02:36:15

Label at a glance#

ProductSpleen

Active ingredientBOS TAURUS SPLEEN

Label structure9 sections

Indications and uses

For temporary relief of symptoms due to spleen dysregulation.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Three sprays per day. Hold in mouth for two minutes.

Contacts and useful links#

PhoneLabel contact1-800-288-9525

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Spleen 6X.

PURPOSE:

OTC - PURPOSE SECTION

Spleen - detoxification**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms due to spleen dysregulation.**

**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

• Three sprays per day.

Hold in mouth for two minutes.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric Acid, Demineralized Water, Ethanol 0.05%, Glycerin, Sodium Benzoate.

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
SPLEEN 6X
HOMEOPATHIC
1 fl. oz. (30 mL)

SPLEEN 6X

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0810184340355	GTIN-13: 0810184340355 EAN-13: 0810184340355 GTIN-12: 810184340355 UPC-A: 810184340355 GTIN storage (14 digits): 00810184340355	BANI0113 Spleen 6X 3-20-25.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43857-0119-1	2023-07-18	C162847	48780-1	f386c649-f457-0266-e053-dadaa90a7c1a	DRUG FACTS:
43857-0119-1	2023-01-30	C162847	48780-1	f386c649-f457-0266-e053-dadaa90a7c1a	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43857-0119-1	Spleen	30 mL in 1 BOTTLE, SPRAY	LIQUID	30		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BOS TAURUS SPLEEN	ACTIVE INGREDIENT	190Q9MB3U3	1
BOS TAURUS SPLEEN	ACTIVE MOIETY	190Q9MB3U3	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Spleen
Spleen (bovine)
BOS TAURUS SPLEEN
WATER
GLYCERIN
SODIUM BENZOATE
CITRIC ACID MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43857-0119	43857-0119-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BOS TAURUS SPLEEN	190Q9MB3U3	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spleen	SPLEEN (BOVINE)	BioActive Nutritional, Inc.	cb56c58f-2f2f-4803-8659-9a34681a9b8e	2025-12-15	Warnings	Exact identifier ndc (package): 43857-0119-1 ndc (product): 43857-0119 ndc11 (package): 43857011901 spl id: 7912225e-e143-4677-ac05-eb23922b04c8 spl set id: cb56c58f-2f2f-4803-8659-9a34681a9b8e

Reported adverse events (FAERS/openFDA)#

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