Tobaccotox

Product NDC
43857-0578
11-digit product format
438570578
Labeler code
43857
Product ID
43857-0578_127c7bc1-5ff4-49ed-b5dc-2bdb4ce59ca5
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Kali Phosphoricum, Cactus Grandiflorus, Eucalyptus Globulus, Lobelia Inflata, Daphne Indica, Mentholum, Ignatia Amara, Nux Vomica, Staphysagria, Tabacum, Benzinum, Naphthalinum
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-02-18
Substance
AVENA SATIVA FLOWERING TOP; BENZENE; DAPHNE ODORA BARK; DELPHINIUM STAPHISAGRIA SEED; DIBASIC POTASSIUM PHOSPHATE; EUCALYPTUS GLOBULUS LEAF; LOBELIA INFLATA WHOLE; MENTHOL, UNSPECIFIED FORM; NAPHTHALENE; SELENICEREUS GRANDIFLORUS STEM; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF
Active strength
1; 15; 4; 12; 2; 3; 3; 4; 15; 3; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tobaccotox
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP1 [hp_X]/mL
DIBASIC POTASSIUM PHOSPHATE15 [hp_X]/mL
SELENICEREUS GRANDIFLORUS STEM4 [hp_X]/mL
EUCALYPTUS GLOBULUS LEAF12 [hp_X]/mL
LOBELIA INFLATA WHOLE2 [hp_X]/mL
DAPHNE ODORA BARK3 [hp_X]/mL
MENTHOL, UNSPECIFIED FORM3 [hp_X]/mL
STRYCHNOS IGNATII SEED4 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED3 [hp_X]/mL
TOBACCO LEAF12 [hp_X]/mL
BENZENE12 [hp_X]/mL
NAPHTHALENE12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 13 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup
CI71S98N1ZInternal UNII lookup
7114SV0MYKInternal UNII lookup
S546YLW6E6Internal UNII lookup
9PP1T3TC5UInternal UNII lookup
JSJ34YQJ5DInternal UNII lookup
L7T10EIP3AInternal UNII lookup
1NM3M2487KInternal UNII lookup
269XH13919Internal UNII lookup
00543AP1JVInternal UNII lookup
6YR2608RSUInternal UNII lookup
J64922108FInternal UNII lookup
2166IN72UNInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b286c7fd-e456-49bf-bb82-0fd32eeb3723Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0578-12023-10-13C16284748780-1f386c64a-48ed-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0578-12023-01-30C16284748780-1f386c64a-48ed-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0578-1Tobaccotox30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0578TOBACCOTOX (AVENA SATIVA, KALI PHOSPHORICUM, CACTUS GRANDIFLORUS, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, DAPHNE INDICA, MENTHOLUM, IGNATIA AMARA, NUX VOMICA, STAPHYSAGRIA, TABACUM, BENZINUM, NAPHTHALINUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]2Current NDC, Legacy NDC, 1 package rows20231014_b286c7fd-e456-49bf-bb82-0fd32eeb3723.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
TobaccotoxAVENA SATIVA, KALI PHOSPHORICUM, CACTUS GRANDIFLORUS, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, DAPHNE INDICA, MENTHOLUM, IGNATIA AMARA, NUX VOMICA, STAPHYSAGRIA, TABACUM, BENZINUM, NAPHTHALINUMBioActive Nutritional, Inc.b286c7fd-e456-49bf-bb82-0fd32eeb37232026-05-18WarningsExact identifier
ndc (product): 43857-0578

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0578-14385705780130 mL in 1 BOTTLE, DROPPER (43857-0578-1) 30 ml2021-02-180000-00-00NoNoCurrent