Tobaccostat

Product NDC
44911-0458
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
CADMIUM SULFIDE12 [hp_X]/mL
CAPSICUM3 [hp_X]/mL
DAPHNE ODORA BARK12 [hp_X]/mL
DIEFFENBACHIA SEGUINE12 [hp_X]/mL
LOBELIA INFLATA WHOLE3 [hp_X]/mL
PAULLINIA CUPANA SEED3 [hp_X]/mL
PHOSPHORIC ACID12 [hp_X]/mL
SPIGELIA ANTHELMIA WHOLE12 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED12 [hp_X]/mL
TOBACCO LEAF4 [hp_X]/mL
VALERIAN1 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMA9CQJ3F7F, 057EZR4Z7Q, 00UK7646FG, JSJ34YQJ5D, 01800C6E6B, 9PP1T3TC5U, C21GE7524R, E4GA8884NN, WYT05213GE, 269XH13919, 6YR2608RSU, JWF5YAW3QW

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

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