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 3
Active ingredientMYCOPLASMA PNEUMONIAE, PROTEUS INCONSTANS, CANDIDA ALBICANS, ESCHERICHIA COLI, MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS, PASTEURELLA MULTOCIDA, STREPTOCOCCUS PNEUMONIAE, THUJA OCCIDENTALIS LEAFY TWIG, PHYTOLACCA AMERICANA ROOT, LEGIONELLA PNEUMOPHILA, SHIGELLA SONNEI
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

Mycoplasma Pneumoniae 9X, 30X, 60X, Proteus (Vulgaris) 12X, 30X, 60X, Candida Albicans 15X, 30X, 60X, Colibacillinum Cum Natrum Muriaticum 15X, 30X, 60X, Mycobacterium Paratuberculosis 15X, 30X, 60X, Pasteurellosis (Pasteurella Multocida) 15X, 30X, 60X, Pneumococcinum 15X, 30X, 60X, Thuja Occidentalis 15X, 30X, 60X, Mycobacterium Avium Paratuberculosis 28X, 30X, 60X, Phytolacca Decandra 6C, 12C, 30C, 60C, Legionella Pneumophila 15C, 30C, 60C, Shigella Sonnei 15C, 30C, 60C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool 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 temporary relief of fever and chills. Promotes a productive wet cough and the coughing up of phlegm. expectorant. Helps relieve the presence of mucus in the stool 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 50181-0078-1

Homeopathic

BioTox Bac 3

1 fl oz (30 ml)

BioTox Bac 3BioTox Bac 3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50181-0078-12025-06-06C16284748780-1f386c649-a123-0266-e053-dadaa90a7c1aDRUG FACTS:
50181-0078-12023-01-30C16284748780-1f386c649-a123-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50181-0078-1BioTox Bac330 mL in 1 BOTTLE, DROPPERLIQUID302

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50181-007850181-0078-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MYCOPLASMA PNEUMONIAEJQE470FAD0ACTIB
PROTEUS INCONSTANSUTX536WN6NACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
ESCHERICHIA COLI514B9K0L10ACTIB
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSISXH0F4IP2RXACTIB
PASTEURELLA MULTOCIDAIX56B2GQX6ACTIB
STREPTOCOCCUS PNEUMONIAEBT6U234YR2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
LEGIONELLA PNEUMOPHILATJR6ZFY0F0ACTIB
SHIGELLA SONNEIOO358E3009ACTIB
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 3MYCOPLASMA PNEUMONIAE, PROTEUS (VULGARIS), CANDIDA ALBICANS, COLIBACILLINUM CUM NATRUM MURIATICUM, MYCOBACTERIUM PARATUBERCULOSIS, PASTEURELLOSIS (PASTEURELLA MULTOCIDA), PNEUMOCOCCINUM, THUJA OCCIDENTALIS, MYCOBACTERIUM AVIUM PARATUBERCULOSIS, PHYTOLACCA DECANDRA, LEGIONELLA PNEUMOPHILA, SHIGELLA SONNEIThe Wellness Center for Research and Education, Inc.29f1cba2-0bb6-43bf-a630-afc8fcb1ec812025-06-06WarningsExact identifier
ndc (package): 50181-0078-1
ndc (product): 50181-0078
ndc11 (package): 50181007801
spl id: 11230476-2e97-4248-a7da-be620decae45
spl set id: 29f1cba2-0bb6-43bf-a630-afc8fcb1ec81

Reported adverse events (FAERS/openFDA)#

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