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BIOTOX

Drug Facts:

Approved
Approval ID

09a3f8c9-0b00-4739-a04f-4ade3ce97761

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

The Wellness Center for Research and Education, Inc.

DUNS: 832363993

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cochlearia Armoracia, Varicella Zoster Nosode, Spleen (Suis), Thymus (Suis), Hepar Suis, Epstein-Barr Virus Nosode, Morbillinum, Meningococcus Nosode, Parotidinum, Rubella Nosode, Poliomyelitis Nosode

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50181-0042
Product Classification
G
Generic Name
Cochlearia Armoracia, Varicella Zoster Nosode, Spleen (Suis), Thymus (Suis), Hepar Suis, Epstein-Barr Virus Nosode, Morbillinum, Meningococcus Nosode, Parotidinum, Rubella Nosode, Poliomyelitis Nosode
Product Specifications
Route of AdministrationORAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (13)

HORSERADISHActive
Quantity: 3 [hp_X] in 1 mL
Code: 8DS6G120HJ
Classification: ACTIB
SUS SCROFA SPLEENActive
Quantity: 8 [hp_X] in 1 mL
Code: 92AMN5J79Y
Classification: ACTIB
SUS SCROFA THYMUSActive
Quantity: 8 [hp_X] in 1 mL
Code: 7B69B0BD62
Classification: ACTIB
MEASLES VIRUSActive
Quantity: 12 [hp_X] in 1 mL
Code: HT3R7C012Q
Classification: ACTIB
MUMPS VIRUSActive
Quantity: 15 [hp_X] in 1 mL
Code: YF0S03R447
Classification: ACTIB
RUBELLA VIRUSActive
Quantity: 30 [hp_X] in 1 mL
Code: U751HEX436
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HUMAN HERPESVIRUS 3Active
Quantity: 6 [hp_X] in 1 mL
Code: 9885M7D6JP
Classification: ACTIB
PORK LIVERActive
Quantity: 8 [hp_X] in 1 mL
Code: 6EC706HI7F
Classification: ACTIB
JAPANESE ENCEPHALITIS VIRUSActive
Quantity: 15 [hp_X] in 1 mL
Code: P07E7XWU9D
Classification: ACTIB
HUMAN HERPESVIRUS 4Active
Quantity: 9 [hp_X] in 1 mL
Code: 2A26YW7PNX
Classification: ACTIB
POLIOVIRUSActive
Quantity: 30 [hp_C] in 1 mL
Code: FZJ641678T
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/28/2025

PACKAGE LABEL DISPLAY

Dr. Theresa Dale's

NDC 50181-0042-1

Homeopathic

BioTox

V-MMR

1 fl oz (30 ml)

BioTox V-MMR

BioTox V-MMR

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/15/2015

INDICATIONS:

For temporary relief of skin rash, childhood illness, headache, weight loss, mental and physical fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling, stiffness of limbs.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/15/2015

ACTIVE INGREDIENTS:

Cochlearia Armoracia 3X, Varicella Zoster Nosode 6X, 8X, 12X, 30X, 200X, 2LM, Spleen (Suis) 8X, Thymus (Suis) 8X, Hepar Suis 8X, Epstein-Barr Virus Nosode 9X, Morbillinum 12X, 30X, 30C, Meningococcus Nosode 15X, 30X, 200X, Parotidinum 15X, 30X, 200X, Rubella Nosode 30X, Poliomyelitis Nosode 30C.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/15/2015

INDICATIONS:

For temporary relief of skin rash, childhood illness, headache, weight loss, mental and physical fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling, stiffness of limbs.

WARNINGS SECTION

LOINC: 34071-1Updated: 4/15/2015

WARNINGS:

If pregnant or breast-feeding, ask a health 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/15/2015

KEEP OUT OF REACH OF CHILDREN:

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/15/2015

DIRECTIONS:

5 drops 2 or 3 times per day, on an empty stomach, 5 days per week or until symptoms abate. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/15/2015

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/15/2015

QUESITONS:

MFD FOR:

The Wellness Center for

Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard CA 93035

1-866-962-6484

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BIOTOX - FDA Drug Approval Details