FDA.reportPublic FDA data

Bio Myelin Protein

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:35:44

Label at a glance#

ProductBio Myelin Protein
Active ingredientSUS SCROFA CEREBRUM
Label structure9 sections

Indications and uses

For temporary relief of minor burning pains on hands and feet.** **Claims based on traditional homeopathic practice, not accepted medial evidence. Not FDA evaluated.

Dosage and administration

• 1 spray under the tongue 3 times per day. • 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

Cerebrum Suis 6X, 8X, 12X.

PURPOSE:

OTC - PURPOSE SECTION

Cerebrum Suis - restlessness**

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

USES:

INDICATIONS & USAGE SECTION

For temporary relief of minor burning pains on hands and feet.**

**Claims based on traditional homeopathic practice, not accepted medial 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

• 1 spray under the tongue 3 times per day.

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric Acid, Demineralized Water, Ethanol 0.06%, 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

BIO MYELIN

PROTEIN

HOMEOPATHIC

1 fl. oz. (30 mL)

Bio Myelin ProteinBio Myelin Protein

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810184340317GTIN-13: 0810184340317
EAN-13: 0810184340317
GTIN-12: 810184340317
UPC-A: 810184340317
GTIN storage (14 digits): 00810184340317		BANI0093 Bio Myelin Protein 6-20-25.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0443-12023-06-06C16284748780-1f386c64a-3cf5-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0443-12023-01-30C16284748780-1f386c64a-3cf5-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0443-1Bio Myelin Protein30 mL in 1 BOTTLE, SPRAYSPRAY305

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-044343857-0443-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUS SCROFA CEREBRUM4GB5DQR532ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

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
Bio Myelin ProteinCEREBRUM SUISBioActive Nutritional, Inc.4f2a6f33-9d6c-4c3e-9de1-6305f353ca462025-12-11WarningsExact identifier
ndc (package): 43857-0443-1
ndc (product): 43857-0443
ndc11 (package): 43857044301
spl id: 12b731aa-31f7-467d-b8e4-5eeeee5c143b
spl set id: 4f2a6f33-9d6c-4c3e-9de1-6305f353ca46

Reported adverse events (FAERS/openFDA)#

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