FDA.reportPublic FDA data

Tobacco Withdrawal

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:55

Label at a glance#

ProductTobacco Withdrawal
Active ingredientTOBACCO LEAF, ECHINACEA, UNSPECIFIED, TARAXACUM OFFICINALE, VALERIAN, CHIONANTHUS VIRGINICUS BARK, CINCHONA OFFICINALIS BARK, DAPHNE ODORA BARK, STRYCHNOS IGNATII SEED, IRIS VERSICOLOR ROOT, LYCOPODIUM CLAVATUM SPORE, NICOTINE, STRYCHNOS NUX-VOMICA SEED, TOXICODENDRON PUBESCENS LEAF, SCUTELLARIA LATERIFLORA WHOLE, ARSENIC TRIOXIDE, BENZOIC ACID, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, DIEFFENBACHIA SEGUINE, LYTTA VESICATORIA, CEANOTHUS AMERICANUS LEAF, CHELIDONIUM MAJUS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 pellets by mouth as needed or as directed by a health professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Taraxacum 6x, Valeriana 6x, Arsenicum alb. 15x, Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Daphne indica 15x, Ignatia 15x, Iris versicolor 15x, Lycopodium 15x, Nicotinum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Scutellaria lateriflora 15x, Tabacum 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-253555714-2535-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOBACCO LEAF6YR2608RSUACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
VALERIANJWF5YAW3QWACTIB
CHIONANTHUS VIRGINICUS BARKS9Y4B22U2EACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DAPHNE ODORA BARKJSJ34YQJ5DACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
NICOTINE6M3C89ZY6RACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SCUTELLARIA LATERIFLORA WHOLE7BP4DH5PDCACTIB
SUCROSEC151H8M554IACT
ARSENIC TRIOXIDES7V92P67HOACTIB
BENZOIC ACID8SKN0B0MIMACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
DIEFFENBACHIA SEGUINE01800C6E6BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB

Source Document#

Source XML

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 (package): 55714-2535-1
ndc (product): 55714-2535
ndc11 (package): 55714253501
spl id: 2dd1c759-635f-a5e6-e063-6294a90ae727
spl set id: 9d399697-69dc-217d-e053-2a95a90a65e4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.