BioTox Bac

Product NDC
50181-0077
Requested package NDC
50181-0077-1
11-digit product format
501810077
Labeler code
50181
Product ID
50181-0077_f3a0b5f3-228c-4388-b7f5-b76746c2928e
Type
HUMAN OTC DRUG
Nonproprietary name
Bacillus 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 Uberis
Dosage form
LIQUID
Route
ORAL
Labeler
The Wellness Center for Research and Education, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-10-04
Marketing end
2026-10-26
Substance
CHLAMYDIA TRACHOMATIS; CLOSTRIDIUM PERFRINGENS; CLOSTRIDIUM TETANI; ENTEROCOCCUS FAECALIS; LISTERIA MONOCYTOGENES; NEISSERIA MENINGITIDIS; PHYTOLACCA AMERICANA ROOT; SHIGELLA DYSENTERIAE; STREPTOCOCCUS AGALACTIAE; STREPTOCOCCUS DYSGALACTIAE; STREPTOCOCCUS EQUINUS; STREPTOCOCCUS MUTANS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS UBERIS; STREPTOCOCCUS VIRIDANS GROUP
Active strength
15; 15; 15; 15; 15; 27; 6; 15; 15; 15; 32; 15; 12; 32; 15 [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
NDC exclude flag
No
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
BioTox Bac
Brand name suffix
2

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOSTRIDIUM TETANI15 [hp_X]/mL
CHLAMYDIA TRACHOMATIS15 [hp_C]/mL
STREPTOCOCCUS VIRIDANS GROUP15 [hp_X]/mL
NEISSERIA MENINGITIDIS15 [hp_C]/mL
PHYTOLACCA AMERICANA ROOT15 [hp_C]/mL
STREPTOCOCCUS PNEUMONIAE27 [hp_X]/mL
CLOSTRIDIUM PERFRINGENS6 [hp_C]/mL
SHIGELLA DYSENTERIAE15 [hp_C]/mL
ENTEROCOCCUS FAECALIS15 [hp_C]/mL
LISTERIA MONOCYTOGENES15 [hp_C]/mL
STREPTOCOCCUS AGALACTIAE32 [hp_C]/mL
STREPTOCOCCUS DYSGALACTIAE15 [hp_C]/mL
STREPTOCOCCUS MUTANS12 [hp_C]/mL
STREPTOCOCCUS EQUINUS32 [hp_C]/mL
STREPTOCOCCUS UBERIS15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 15 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
751E8J54VMInternal UNII lookup
T6NI39QU44Internal UNII lookup
NNV2379HKRInternal UNII lookup
V3TP2MD7F3Internal UNII lookup
11E6VI8VEGInternal UNII lookup
BT6U234YR2Internal UNII lookup
OVP6XX033EInternal UNII lookup
1EP6R5562JInternal UNII lookup
15E04LZ9CTInternal UNII lookup
3O44K14A86Internal UNII lookup
2B3763S671Internal UNII lookup
LN0SH02Y5MInternal UNII lookup
5C7J33MJJ1Internal UNII lookup
R2P4NKP3ZKInternal UNII lookup
O84V4ZK4BXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1554cd2d-e064-46f1-a635-2c80191a7b9eAvailable on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50181-0077BIOTOX BAC 2 (BACILLUS 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 UBERIS) LIQUID [THE WELLNESS CENTER FOR RESEARCH AND EDUCATION, INC.]1Current NDC, Legacy NDC, 1 package rows20211005_1554cd2d-e064-46f1-a635-2c80191a7b9e.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50181-0077-15018100770130 mL in 1 BOTTLE, DROPPER (50181-0077-1) 30 ml2021-10-042026-10-26NoNoCurrent