Home NDC 50181-0077-1 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 CLOSTRIDIUM 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
Active strength 15; 15; 15; 27; 6; 12; 15; 15; 15; 15; 15; 15; 15; 32; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/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_C]/mL; [hp_C]/mL; [hp_C]/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 date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base BioTox Bac
Brand name suffix 2 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOSTRIDIUM TETANI 15 [hp_X]/mL CHLAMYDIA TRACHOMATIS 15 [hp_X]/mL STREPTOCOCCUS VIRIDANS GROUP 15 [hp_X]/mL NEISSERIA MENINGITIDIS 27 [hp_X]/mL PHYTOLACCA AMERICANA ROOT 6 [hp_C]/mL STREPTOCOCCUS PNEUMONIAE 12 [hp_C]/mL CLOSTRIDIUM PERFRINGENS 15 [hp_C]/mL SHIGELLA DYSENTERIAE 15 [hp_C]/mL ENTEROCOCCUS FAECALIS 15 [hp_C]/mL LISTERIA MONOCYTOGENES 15 [hp_C]/mL STREPTOCOCCUS AGALACTIAE 15 [hp_C]/mL STREPTOCOCCUS DYSGALACTIAE 15 [hp_C]/mL STREPTOCOCCUS MUTANS 15 [hp_C]/mL STREPTOCOCCUS EQUINUS 32 [hp_C]/mL STREPTOCOCCUS UBERIS 32 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 15 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50181-0077-1 BioTox Bac2 30 mL in 1 BOTTLE, DROPPER LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50181-0077 BIOTOX 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.] 1 Current NDC, Legacy NDC, 1 package rows 20211005_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BioTox 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 The Wellness Center for Research and Education, Inc. 1554cd2d-e064-46f1-a635-2c80191a7b9e 2025-06-06 Warnings Exact identifier ndc (package): 50181-0077-1 ndc (product): 50181-0077 ndc11 (package): 50181007701
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50181-0077-1 50181007701 30 mL in 1 BOTTLE, DROPPER (50181-0077-1) 30 ml 2021-10-04 2026-10-26 No No Current