Tobacco Withdrawal

Product NDC
55714-2535
11-digit product format
557142535
Labeler code
55714
Product ID
55714-2535_2dd1c759-635f-a5e6-e063-6294a90ae727
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
PELLET
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]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55714-2535-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-2535-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-2535-10efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 21 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6YR2608RSUInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
39981FM375Internal UNII lookup
JWF5YAW3QWInternal UNII lookup
S003A158SBInternal UNII lookup
JSJ34YQJ5DInternal UNII lookup
1NM3M2487KInternal UNII lookup
X43D4L3DQCInternal UNII lookup
C88X29Y479Internal UNII lookup
6M3C89ZY6RInternal UNII lookup
269XH13919Internal UNII lookup
6IO182RP7AInternal UNII lookup
7BP4DH5PDCInternal UNII lookup
S7V92P67HOInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
T7J046YI2BInternal UNII lookup
01800C6E6BInternal UNII lookup
3Q034RO3BTInternal UNII lookup
25B1Y14T8NInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d399697-69dc-217d-e053-2a95a90a65e4Available on FDA.report

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
55714-2535-1Tobacco Withdrawal28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2535TOBACCO 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) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250212_9d399697-69dc-217d-e053-2a95a90a65e4.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
Tobacco WithdrawalARSENICUM 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, VALERIANANewton Laboratories, Inc.9d399697-69dc-217d-e053-2a95a90a65e42025-02-10WarningsExact identifier
ndc (product): 55714-2535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-2535-15571425350128 g in 1 BOTTLE, GLASS (55714-2535-1) 28 g2019-01-010000-00-00NoNoCurrent