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

Additional Listing Data#

Finished product
Yes
Brand name base
BioTox Dental Foci Repair

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE4 [hp_C]/mL
ARNICA MONTANA WHOLE3 [hp_C]/mL
ATROPA BELLADONNA6 [hp_C]/mL
CALCIUM SULFIDE6 [hp_C]/mL
HEKLA LAVA6 [hp_C]/mL
HYPERICUM PERFORATUM WHOLE3 [hp_C]/mL
MERCURIUS SOLUBILIS4 [hp_C]/mL
PLANTAGO MAJOR WHOLE3 [hp_C]/mL
SILICON DIOXIDE6 [hp_C]/mL
SILVER NITRATE6 [hp_C]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU0NQ8555JD, O80TY208ZW, WQZ3G9PF0H, 1MBW07J51Q, C21158IIRK, XK4IUX8MNB, 324Y4038G2, W2469WNO6U, ETJ7Z6XBU4, 95IT3W8JZE

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

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