Tobaccostat

Product NDC
44911-0458
Requested package NDC
44911-0458-1
11-digit product format
449110458
Labeler code
44911
Product ID
44911-0458_ca5753fd-d64b-4c4e-9bdb-7082e91ffc9d
Type
HUMAN OTC DRUG
Nonproprietary name
Avena Sativa, Valeriana Officinalis, Capsicum Annuum, Paullinia Sorbilis, Lobelia Inflata, Tabacum, Cadmium Sulphuratum, Caladium Seguinum, Daphne Indica, Nux Vomica, Phosphoricum Acidum, Spigelia Anthelmia, Staphysagria
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-06-15
Substance
AVENA SATIVA FLOWERING TOP; CADMIUM SULFIDE; CAPSICUM; DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; LOBELIA INFLATA WHOLE; PAULLINIA CUPANA SEED; PHOSPHORIC ACID; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS NUX-VOMICA SEED; TOBACCO LEAF; VALERIAN
Active strength
1; 12; 3; 12; 12; 3; 3; 12; 12; 12; 4; 1 [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], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVENA SATIVA FLOWERING TOP1 [hp_X]/mL
VALERIAN12 [hp_X]/mL
CAPSICUM3 [hp_X]/mL
PAULLINIA CUPANA SEED12 [hp_X]/mL
LOBELIA INFLATA WHOLE12 [hp_X]/mL
TOBACCO LEAF3 [hp_X]/mL
CADMIUM SULFIDE3 [hp_X]/mL
DIEFFENBACHIA SEGUINE12 [hp_X]/mL
DAPHNE ODORA BARK12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
PHOSPHORIC ACID4 [hp_X]/mL
SPIGELIA ANTHELMIA WHOLE1 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MA9CQJ3F7FInternal UNII lookup
JWF5YAW3QWInternal UNII lookup
00UK7646FGInternal UNII lookup
C21GE7524RInternal UNII lookup
9PP1T3TC5UInternal UNII lookup
6YR2608RSUInternal UNII lookup
057EZR4Z7QInternal UNII lookup
01800C6E6BInternal UNII lookup
JSJ34YQJ5DInternal UNII lookup
269XH13919Internal UNII lookup
E4GA8884NNInternal UNII lookup
WYT05213GEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f4ad1d8-4efb-4660-bab7-4fb05ff4f909Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0458-12023-08-28C16284748780-1f386c649-a9ce-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0458-12023-01-30C16284748780-1f386c649-a9ce-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0458-1Tobaccostat30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0458TOBACCOSTAT (AVENA SATIVA, VALERIANA OFFICINALIS, CAPSICUM ANNUUM, PAULLINIA SORBILIS, LOBELIA INFLATA, TABACUM, CADMIUM SULPHURATUM, CALADIUM SEGUINUM, DAPHNE INDICA, NUX VOMICA, PHOSPHORICUM ACIDUM, SPIGELIA ANTHELMIA, STAPHYSAGRIA) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20230829_5f4ad1d8-4efb-4660-bab7-4fb05ff4f909.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
TobaccostatAVENA SATIVA, VALERIANA OFFICINALIS, CAPSICUM ANNUUM, PAULLINIA SORBILIS, LOBELIA INFLATA, TABACUM, CADMIUM SULPHURATUM, CALADIUM SEGUINUM, DAPHNE INDICA, NUX VOMICA, PHOSPHORICUM ACIDUM, SPIGELIA ANTHELMIA, STAPHYSAGRIAEnergique, Inc.5f4ad1d8-4efb-4660-bab7-4fb05ff4f9092023-08-28WarningsExact identifier
ndc (package): 44911-0458-1
ndc (product): 44911-0458
ndc11 (package): 44911045801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0458-14491104580130 mL in 1 BOTTLE, DROPPER (44911-0458-1) 30 ml2018-06-150000-00-00NoNoCurrent