BioTox Bac

Product NDC
50181-0078
11-digit product format
501810078
Labeler code
50181
Product ID
50181-0078_11230476-2e97-4248-a7da-be620decae45
Type
HUMAN OTC DRUG
Nonproprietary name
Mycoplasma 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 Sonnei
Dosage form
LIQUID
Route
ORAL
Labeler
The Wellness Center for Research and Education, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-11-08
Marketing end
2026-12-09
Substance
CANDIDA ALBICANS; ESCHERICHIA COLI; LEGIONELLA PNEUMOPHILA; MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS; MYCOPLASMA PNEUMONIAE; PASTEURELLA MULTOCIDA; PHYTOLACCA AMERICANA ROOT; PROTEUS INCONSTANS; SHIGELLA SONNEI; STREPTOCOCCUS PNEUMONIAE; THUJA OCCIDENTALIS LEAFY TWIG
Active strength
15; 15; 15; 15; 9; 15; 6; 12; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50181-0078-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50181-0078-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50181-0078-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50181-0078-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50181-0078-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50181-0078-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50181-0078-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50181-0078-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50181-0078-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50181-0078-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50181-0078-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50181-0078-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50181-0078-11332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
BioTox Bac
Brand name suffix
3

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MYCOPLASMA PNEUMONIAE15 [hp_X]/mL
PROTEUS INCONSTANS15 [hp_X]/mL
CANDIDA ALBICANS15 [hp_C]/mL
ESCHERICHIA COLI15 [hp_X]/mL
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS9 [hp_X]/mL
PASTEURELLA MULTOCIDA15 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE6 [hp_C]/mL
THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT15 [hp_C]/mL
LEGIONELLA PNEUMOPHILA15 [hp_X]/mL
SHIGELLA SONNEI15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JQE470FAD0Internal UNII lookup
UTX536WN6NInternal UNII lookup
4D7G21HDBCInternal UNII lookup
514B9K0L10Internal UNII lookup
XH0F4IP2RXInternal UNII lookup
IX56B2GQX6Internal UNII lookup
BT6U234YR2Internal UNII lookup
1NT28V9397Internal UNII lookup
11E6VI8VEGInternal UNII lookup
TJR6ZFY0F0Internal UNII lookup
OO358E3009Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29f1cba2-0bb6-43bf-a630-afc8fcb1ec81Available on FDA.report

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50181-0078BIOTOX BAC 3 (MYCOPLASMA 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 SONNEI) LIQUID [THE WELLNESS CENTER FOR RESEARCH AND EDUCATION, INC.]1Current NDC, Legacy NDC, 1 package rows20211109_29f1cba2-0bb6-43bf-a630-afc8fcb1ec81.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 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 (product): 50181-0078

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50181-0078-15018100780130 mL in 1 BOTTLE, DROPPER (50181-0078-1) 30 ml2021-11-082026-12-09NoNoCurrent