FDA.reportPublic FDA data

Tree Antigen

Product NDC
43857-0520
11-digit product format
438570520
Labeler code
43857
Product ID
43857-0520_0d6a889b-4780-48b6-a730-f3ee58c18d0f
Type
HUMAN OTC DRUG
Nonproprietary name
Tea Tree Essential Oil, Arsenicum Album, Lycopodium Clavatum, Pulsatilla (Pratensis).
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-08-08
Substance
ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS WHOLE; TEA TREE OIL
Active strength
12; 12; 12; 6 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tree Antigen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
TEA TREE OIL6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, C88X29Y479, 8E272251DI, VIF565UC2G

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0520-12023-06-07C16284748780-1ba0f9c33-2887-a910-e053-dadaa90a0b85Drug Facts:
43857-0520-12021-01-29C16284748780-1ba0f9c33-2887-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0520-1Tree Antigen30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0520TREE ANTIGEN (TEA TREE ESSENTIAL OIL, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS).) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20230609_c6b0f199-e44e-4892-b56b-766cf0bc4b62.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43857-0520-14385705200130 mL in 1 BOTTLE, DROPPER (43857-0520-1) 30 ml2019-08-08NoNoCurrent