FDA.reportPublic FDA data

BioTox T

Product NDC
50181-0058
Requested package NDC
50181-0058-1
11-digit product format
501810058
Labeler code
50181
Product ID
50181-0058_7e4e9b10-0acf-4c34-9a1a-6c41230e6208
Type
HUMAN OTC DRUG
Nonproprietary name
Bacillus Tetani, Ledum Palustre
Dosage form
LIQUID
Route
ORAL
Labeler
The Wellness Center For Research and Education
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-02-27
Marketing end
0000-00-00
Substance
CLOSTRIDIUM TETANI; RHODODENDRON TOMENTOSUM LEAFY TWIG
Active strength
30 [hp_C]/mL; [hp_C]/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50181-005850181-0058-1DDiscontinued by firm2026-10-05

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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50181-0058-12025-05-30C16284748780-1f386c64a-1d0d-0266-e053-dadaa90a7c1aDrug Facts:
50181-0058-12023-01-30C16284748780-1f386c64a-1d0d-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50181-0058-1BioTox T30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50181-0058BIOTOX T (BACILLUS TETANI, LEDUM PALUSTRE) LIQUID [THE WELLNESS CENTER FOR RESEARCH AND EDUCATION]2Legacy NDC, 1 package rows20210617_7c6ed561-340d-4053-bec0-8be0906bbcd8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50181-0058-15018100580130 mL in 1 BOTTLE, DROPPER (50181-0058-1) 30 ml2018-02-270000-00-00NoNoCurrent