FDA.reportPublic FDA data

BioTox Bac

Manufacturer
The Wellness Center for Research and Education, Inc. | Apotheca Company
Effective date
2025-06-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:33:55

Label at a glance#

ProductBioTox Bac 2
Active ingredientCLOSTRIDIUM TETANI, CHLAMYDIA TRACHOMATIS, STREPTOCOCCUS VIRIDANS GROUP, NEISSERIA MENINGITIDIS, PHYTOLACCA AMERICANA ROOT, STREPTOCOCCUS PNEUMONIAE, CLOSTRIDIUM PERFRINGENS, SHIGELLA DYSENTERIAE, ENTEROCOCCUS FAECALIS, LISTERIA MONOCYTOGENES, STREPTOCOCCUS AGALACTIAE, STREPTOCOCCUS DYSGALACTIAE, STREPTOCOCCUS MUTANS, STREPTOCOCCUS EQUINUS, STREPTOCOCCUS UBERIS
Label structure9 sections

Dosage and administration

5 drops three times daily (under tongus), 5 days per week (between meals, food and beverage), unless otherwise directed by health provider. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Bacillus Tetani 15X, 30X, 60X, Chlamydia Trachomatis 15X 30X, 60X, Streptococcus Viridans 15X, 30X, 60, Meningococcus Nosode 27X, 30X, 60X, Phytolacca Decandra 6C, 12C, 30C, 60C, Pneumococcinum 12C, 30C, 60C, Clostridium Perfringens 15C, 30C, 60C, Dysentery Bacillus 15C, 30C, 60C, Enterococcus Faecalis 15C, 30C, 60C, Listeria Monocytogenes 15C, 30C, 60C, Streptococcus Agalactiae 15C, 30C, 60C, Streptococcus Dysgalactiae 15C, 30C, 60C, Streptococcus Mutans 15C, 30C, 60C, Streptococcus Bovis 32C, 60C, Streptococcus Uberis 32C, 60C.

INDICATIONS:

OTC - PURPOSE SECTION

For the temporary relief of fever, sore throat, fatigue, pain and loose stools. 

WARNINGS:

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

5 drops three times daily (under tongus), 5 days per week (between meals, food and beverage), unless otherwise directed by health provider.

Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For the temporary relief of fever, sore throat, fatigue, pain and loose stools.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Organic Ethanol

QUESTONS:

OTC - QUESTIONS SECTION

MFD FOR: The Wellness Center for

Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Theresa Dale's

NDC 50181-0077-1

Homeopathic

BioTox Bac 2

1 fl oz (30 ml)

BioTox Bac 2BioTox Bac 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50181-0077-12025-06-06C16284748780-1f386c64a-2f60-0266-e053-dadaa90a7c1aDRUG FACTS:
50181-0077-12023-01-30C16284748780-1f386c64a-2f60-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50181-0077-1BioTox Bac230 mL in 1 BOTTLE, DROPPERLIQUID302

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50181-007750181-0077-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOSTRIDIUM TETANI751E8J54VMACTIB
CHLAMYDIA TRACHOMATIST6NI39QU44ACTIB
STREPTOCOCCUS VIRIDANS GROUPNNV2379HKRACTIB
NEISSERIA MENINGITIDISV3TP2MD7F3ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
STREPTOCOCCUS PNEUMONIAEBT6U234YR2ACTIB
CLOSTRIDIUM PERFRINGENSOVP6XX033EACTIB
SHIGELLA DYSENTERIAE1EP6R5562JACTIB
ENTEROCOCCUS FAECALIS15E04LZ9CTACTIB
LISTERIA MONOCYTOGENES3O44K14A86ACTIB
STREPTOCOCCUS AGALACTIAE2B3763S671ACTIB
STREPTOCOCCUS DYSGALACTIAELN0SH02Y5MACTIB
STREPTOCOCCUS MUTANS5C7J33MJJ1ACTIB
STREPTOCOCCUS EQUINUSR2P4NKP3ZKACTIB
STREPTOCOCCUS UBERISO84V4ZK4BXACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
BioTox Bac 2BACILLUS TETANI, CHLAMYDIA TRACHOMATIS, STREPTOCOCCUS VIRIDANS, MENINGOCOCCUS NOSODE, PHYTOLACCA DECANDRA, PNEUMOCOCCINUM, CLOSTRIDIUM PERFRINGENS, DYSENTERY BACILLUS, ENTEROCOCCUS FAECALIS, LISTERIA MONOCYTOGENES, STREPTOCOCCUS AGALACTIAE, STREPTOCOCCUS DYSGALACTIAE, STREPTOCOCCUS MUTANS, STREPTOCOCCUS BOVIS, STREPTOCOCCUS UBERISThe Wellness Center for Research and Education, Inc.1554cd2d-e064-46f1-a635-2c80191a7b9e2025-06-06WarningsExact identifier
ndc (package): 50181-0077-1
ndc (product): 50181-0077
ndc11 (package): 50181007701
spl id: f3a0b5f3-228c-4388-b7f5-b76746c2928e
spl set id: 1554cd2d-e064-46f1-a635-2c80191a7b9e

Reported adverse events (FAERS/openFDA)#

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