Tobacco Withdrawal

Product NDC
55714-2534
11-digit product format
557142534
Labeler code
55714
Product ID
55714-2534_2dd1c526-921e-f246-e063-6394a90a707b
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenicum alb., Benzoicum acidum, Berber. vulg., Bryonia, Caladium seguinum, Cantharis, Ceanothus, Chelidonium majus, Chionanthus virginica, Cinchona, Daphne indica, Ignatia, Iris versicolor, Lycopodium, Nicotinum, Nux vom., Rhus toxicodendron, Scutellaria lateriflora, Tabacum, Echinacea, Taraxacum, Valeriana
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-01
Substance
ARSENIC TRIOXIDE; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CINCHONA OFFICINALIS BARK; DAPHNE ODORA BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; LYTTA VESICATORIA; NICOTINE; SCUTELLARIA LATERIFLORA WHOLE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TOBACCO LEAF; TOXICODENDRON PUBESCENS LEAF; VALERIAN
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 6 [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; [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], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cholinergic Nicotinic Agonist [EPC], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Nicotine [CS], Nitrogen Binding Agent [EPC], 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE15 [hp_X]/mL
BENZOIC ACID15 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CEANOTHUS AMERICANUS LEAF15 [hp_X]/mL
CHELIDONIUM MAJUS15 [hp_X]/mL
CHIONANTHUS VIRGINICUS BARK15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
DAPHNE ODORA BARK15 [hp_X]/mL
DIEFFENBACHIA SEGUINE15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
IRIS VERSICOLOR ROOT15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
LYTTA VESICATORIA15 [hp_X]/mL
NICOTINE15 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE15 [hp_X]/mL
STRYCHNOS IGNATII SEED15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
TARAXACUM OFFICINALE6 [hp_X]/mL
TOBACCO LEAF15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
VALERIAN6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, 8SKN0B0MIM, 1TH8Q20J0U, T7J046YI2B, 25B1Y14T8N, 7E889U5RNN, S003A158SB, JSJ34YQJ5D, 01800C6E6B, 4N9P6CC1DX, X43D4L3DQC, C88X29Y479, 3Q034RO3BT, 6M3C89ZY6R, 7BP4DH5PDC, 1NM3M2487K, 269XH13919, 39981FM375, 6YR2608RSU, 6IO182RP7A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2534-1Tobacco Withdrawal30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2534TOBACCO WITHDRAWAL (ARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250212_9d38fd5a-1657-11e5-e053-2a95a90a47ee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2534-15571425340130 mL in 1 BOTTLE, GLASS (55714-2534-1) 30 ml2019-01-010000-00-00NoNoCurrent