Home NDC 50181-0082-1 BioTox Dental Foci Repair
Product NDC 50181-0082
Requested package NDC 50181-0082-1
11-digit product format 501810082
Labeler code 50181
Product ID 50181-0082_ccb14ecf-89db-4afb-a89c-263c28afa851
Type HUMAN OTC DRUG
Nonproprietary name Arnica Montana, Hypericum Perforatum, Plantago Major, Aconitum Napellus, Mercurius Solubilis, Hekla Lava, Argentum Nitricum, Belladonna, Hepar Sulphuris Calcareum, Silicea
Dosage form SPRAY
Route ORAL
Labeler The Wellness Center For Research and Education
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2022-02-14
Marketing end 2027-03-04
Substance ACONITUM NAPELLUS WHOLE; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; CALCIUM SULFIDE; HEKLA LAVA; HYPERICUM PERFORATUM WHOLE; MERCURIUS SOLUBILIS; PLANTAGO MAJOR WHOLE; SILICON DIOXIDE; SILVER NITRATE
Active strength 4; 3; 6; 6; 6; 3; 4; 3; 6; 6 [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…
Additional Listing Data#
Finished product Yes
Brand name base BioTox Dental Foci Repair Active Ingredients# Ingredient, Strength table Ingredient Strength ARNICA MONTANA WHOLE 4 [hp_C]/mL HYPERICUM PERFORATUM WHOLE 3 [hp_C]/mL PLANTAGO MAJOR WHOLE 6 [hp_C]/mL ACONITUM NAPELLUS WHOLE 6 [hp_C]/mL MERCURIUS SOLUBILIS 6 [hp_C]/mL HEKLA LAVA 3 [hp_C]/mL SILVER NITRATE 4 [hp_C]/mL ATROPA BELLADONNA 3 [hp_C]/mL CALCIUM SULFIDE 6 [hp_C]/mL SILICON DIOXIDE 6 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 10 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50181-0082-1 BioTox Dental Foci Repair 30 mL in 1 BOTTLE, SPRAY SPRAY 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50181-0082 BIOTOX DENTAL FOCI REPAIR (ARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEA) SPRAY [THE WELLNESS CENTER FOR RESEARCH AND EDUCATION] 1 Current NDC, Legacy NDC, 1 package rows 20220215_767f8dd2-759f-4662-9b5c-b8832309363d.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 Dental Foci Repair ARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEA The Wellness Center For Research and Education 767f8dd2-759f-4662-9b5c-b8832309363d 2025-06-06 Warnings Exact identifier ndc (package): 50181-0082-1 ndc (product): 50181-0082 ndc11 (package): 50181008201
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50181-0082-1 50181008201 30 mL in 1 BOTTLE, SPRAY (50181-0082-1) 30 ml 2022-02-14 2027-03-04 No No Current