BioTox Dental Foci Repair

Product NDC
50181-0082
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 · 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 packagepackage50181-0082-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50181-0082-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50181-0082-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50181-0082-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50181-0082-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50181-0082-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50181-0082-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50181-0082-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50181-0082-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50181-0082-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50181-0082-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50181-0082-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50181-0082-11332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
BioTox Dental Foci Repair

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA WHOLE4 [hp_C]/mL
HYPERICUM PERFORATUM WHOLE3 [hp_C]/mL
PLANTAGO MAJOR WHOLE6 [hp_C]/mL
ACONITUM NAPELLUS WHOLE6 [hp_C]/mL
MERCURIUS SOLUBILIS6 [hp_C]/mL
HEKLA LAVA3 [hp_C]/mL
SILVER NITRATE4 [hp_C]/mL
ATROPA BELLADONNA3 [hp_C]/mL
CALCIUM SULFIDE6 [hp_C]/mL
SILICON DIOXIDE6 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O80TY208ZWInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
W2469WNO6UInternal UNII lookup
U0NQ8555JDInternal UNII lookup
324Y4038G2Internal UNII lookup
C21158IIRKInternal UNII lookup
95IT3W8JZEInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
1MBW07J51QInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
767f8dd2-759f-4662-9b5c-b8832309363dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50181-0082-12025-06-06C16284748780-11030e365-5597-111a-e063-dadaa90a10e2DRUG FACTS:
50181-0082-12024-01-30C16284748780-11030e365-5597-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50181-0082-1BioTox Dental Foci Repair30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50181-0082BIOTOX 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]1Current NDC, Legacy NDC, 1 package rows20220215_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
ndc (product): 50181-0082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50181-0082-15018100820130 mL in 1 BOTTLE, SPRAY (50181-0082-1) 30 ml2022-02-142027-03-04NoNoCurrent