FDA.reportPublic FDA data

BIOTOX BAC

Manufacturer
The Wellness Center for Research and Education, Inc. | Apotheca Company
Effective date
2021-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:25:16

Label at a glance#

ProductBIOTOX BAC 2
Active ingredientSTREPTOCOCCUS VIRIDANS GROUP, CHLAMYDIA TRACHOMATIS, CLOSTRIDIUM TETANI, NEISSERIA MENINGITIDIS, PHYTOLACCA AMERICANA ROOT, STREPTOCOCCUS AGALACTIAE, STREPTOCOCCUS PNEUMONIAE, ENTEROCOCCUS FAECALIS, STREPTOCOCCUS MUTANS, SHIGELLA DYSENTERIAE, LISTERIA MONOCYTOGENES, STREPTOCOCCUS DYSGALACTIAE, STREPTOCOCCUS UBERIS, CLOSTRIDIUM PERFRINGENS, STREPTOCOCCUS EQUINUS
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

Streptococcus viridans 8X, 12X, 30X, 60X, Chlamydia trachomatis 9X, 30X, 60X, Bacillus tetani 12X, 30X, 60X, Meningococcus nosode 15X, 30X, 60X, Phytolacca decandra 6C, 12C, 30C, 60C, Streptococcus agalactiae 6C, 12C, 30C, 60C, Streptococcus pheumoniae 6C, 12C, 30C, 60C, Enterococcus faecalis 9C, 30C, 60C, Streptococcus mutans 9C, 30C, 60C, Dysentery bacillus 12C, 30C, 60C, Listeria monocytogenes 12C, 30C, 60C, Streptococcus dysgalactiae 12C, 30C, 60C, Streptococcus uberis 12C, 30C, 60C, Clostridium pergringens 15C, 30C, 60C, Streptococcus bovis 30C, 60C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of inflammation, fever, coughing, aching, soreness, limb pain, pale skin, cold hands and feet, rash, sinus and/or throat mucus, glandular swelling, vaginal discharge, vaginal itching, burning when urinating.

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 tempoary relief of inflammation, fever, coughing, aching, soreness, limb pain, pale skin, cold hands and feet, rash, sinus and/or throat mucus, glandular swelling, vaginal discharge, vaginal itcdhing, burning when urinating.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTONS:

OTC - QUESTIONS SECTION

MFD FOR:

The Wellness Center for Research and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Theresa Dale's

NDC 50181-0046-1

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
50181-0046-12021-12-01C16284748780-19d75b9d0-7c42-f424-e053-dadaa90a57ceDrug Facts
50181-0046-12020-01-31C16284748780-19d75b9d0-7c42-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLAMYDIA TRACHOMATISACTIVE INGREDIENTT6NI39QU441
CLOSTRIDIUM PERFRINGENSACTIVE INGREDIENTOVP6XX033E1
CLOSTRIDIUM TETANIACTIVE INGREDIENT751E8J54VM1
ENTEROCOCCUS FAECALISACTIVE INGREDIENT15E04LZ9CT1
LISTERIA MONOCYTOGENESACTIVE INGREDIENT3O44K14A861
NEISSERIA MENINGITIDISACTIVE INGREDIENTV3TP2MD7F31
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
SHIGELLA DYSENTERIAEACTIVE INGREDIENT1EP6R5562J1
STREPTOCOCCUS AGALACTIAEACTIVE INGREDIENT2B3763S6711
STREPTOCOCCUS DYSGALACTIAEACTIVE INGREDIENTLN0SH02Y5M1
STREPTOCOCCUS EQUINUSACTIVE INGREDIENTR2P4NKP3ZK1
STREPTOCOCCUS MUTANSACTIVE INGREDIENT5C7J33MJJ11
STREPTOCOCCUS PNEUMONIAEACTIVE INGREDIENTBT6U234YR21
STREPTOCOCCUS UBERISACTIVE INGREDIENTO84V4ZK4BX1
STREPTOCOCCUS VIRIDANS GROUPACTIVE INGREDIENTNNV2379HKR1
CHLAMYDIA TRACHOMATISACTIVE MOIETYT6NI39QU441
CLOSTRIDIUM PERFRINGENSACTIVE MOIETYOVP6XX033E1
CLOSTRIDIUM TETANIACTIVE MOIETY751E8J54VM1
ENTEROCOCCUS FAECALISACTIVE MOIETY15E04LZ9CT1
LISTERIA MONOCYTOGENESACTIVE MOIETY3O44K14A861
NEISSERIA MENINGITIDISACTIVE MOIETYV3TP2MD7F31
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
SHIGELLA DYSENTERIAEACTIVE MOIETY1EP6R5562J1
STREPTOCOCCUS AGALACTIAEACTIVE MOIETY2B3763S6711
STREPTOCOCCUS DYSGALACTIAEACTIVE MOIETYLN0SH02Y5M1
STREPTOCOCCUS EQUINUSACTIVE MOIETYR2P4NKP3ZK1
STREPTOCOCCUS MUTANSACTIVE MOIETY5C7J33MJJ11
STREPTOCOCCUS PNEUMONIAEACTIVE MOIETYBT6U234YR21
STREPTOCOCCUS UBERISACTIVE MOIETYO84V4ZK4BX1
STREPTOCOCCUS VIRIDANS GROUPACTIVE MOIETYNNV2379HKR1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
50181-004650181-0046-1

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
STREPTOCOCCUS VIRIDANS GROUPNNV2379HKRACTIM
CHLAMYDIA TRACHOMATIST6NI39QU44ACTIB
CLOSTRIDIUM TETANI751E8J54VMACTIB
NEISSERIA MENINGITIDISV3TP2MD7F3ACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
STREPTOCOCCUS AGALACTIAE2B3763S671ACTIB
STREPTOCOCCUS PNEUMONIAEBT6U234YR2ACTIB
ENTEROCOCCUS FAECALIS15E04LZ9CTACTIB
STREPTOCOCCUS MUTANS5C7J33MJJ1ACTIB
SHIGELLA DYSENTERIAE1EP6R5562JACTIB
LISTERIA MONOCYTOGENES3O44K14A86ACTIB
STREPTOCOCCUS DYSGALACTIAELN0SH02Y5MACTIB
STREPTOCOCCUS UBERISO84V4ZK4BXACTIB
CLOSTRIDIUM PERFRINGENSOVP6XX033EACTIB
STREPTOCOCCUS EQUINUSR2P4NKP3ZKACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1e7b6a7a-1e36-4c98-86f3-70f60de01944c79f69ed-49e9-4a71-ba0b-5640730f8aa32021-12-01WarningsExact identifier
spl id: 1e7b6a7a-1e36-4c98-86f3-70f60de01944
spl set id: c79f69ed-49e9-4a71-ba0b-5640730f8aa3

Reported adverse events (FAERS/openFDA)#

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