FDA.reportPublic FDA data

Nicotine Free

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:44

Label at a glance#

ProductNicotine Free
Active ingredientPICEA MARIANA RESIN, ACONITUM NAPELLUS WHOLE, AVENA SATIVA FLOWERING TOP, DIEFFENBACHIA SEGUINE WHOLE, STRYCHNOS IGNATII SEED, LOBELIA INFLATA WHOLE, SUS SCROFA LUNG, STRYCHNOS NUX-VOMICA SEED, PLANTAGO MAJOR WHOLE, ASPIDOSPERMA QUEBRACHO-BLANCO BARK, LOBARIA PULMONARIA, TOBACCO LEAF
Label structure9 sections

Dosage and administration

Adults & children over 12: Spray twice under the tongue 3 times per day. Children under 12: Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each spray) 8.33% of Abies Nigra 10X, Aconitum Napellus 200C, Avena Sativa 1X, Caladium Seguinum 10X, Ignatia Amara 200C, Lobelia Inflata 10X, Lung Suis 6X, Nux Vomica 10X, Plantago Major 3X, Quebracho 10X, Sticta Pulmonaria 200C, Tabacum 200C.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with nicotine withdrawal: craving for cigarettes, nervousness, insomnia, cough.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

If symptoms persist for more than 7 days, consult a doctor.

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

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults & children over 12: Spray twice under the tongue 3 times per day.

Children under 12: Consult a doctor prior to use.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with nicotine withdrawal: craving for cigarettes, nervousness, insomnia, cough.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic Alcohol 20% v/v, Purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

DIST. BY LIDDELL LABORATORIES INC. 

WOODBINE, IA 51579

WWW.LIDDELL.NET 1-800-460-7733

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS

LIDDELL LABORATORIES

EST. 1994

38   Nic

Nicotine Free

HOMEOPATHIC

1.0 FL OZ (30 ml)

Nicotine FreeNicotine Free

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0267-12024-11-04C16284748780-1d6a99b39-6ed1-a426-e053-dadaa90af4c2DRUG FACTS:
50845-0267-12022-01-28C16284748780-1d6a99b39-6ed1-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0267-1Nicotine Free30 mL in 1 BOTTLE, SPRAYSPRAY302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0267NICOTINE FREE (ABIES NIGRA, ACONITUM NAPELLUS, AVENA SATIVA, CALADIUM SEGUINUM, IGNATIA AMARA, LOBELIA INFLATA, LUNG SUIS, NUX VOMICA, PLANTAGO MAJOR, QUEBRACHO, STICTA PULMONARIA, TABACUM) SPRAY [LIDDELL LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20241105_11580c55-cfe8-42d5-b2f4-ab9141c380ad.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-026750845-0267-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
PICEA MARIANA RESIN71AOV0W131ACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
DIEFFENBACHIA SEGUINE WHOLE01800C6E6BACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LOBELIA INFLATA WHOLE9PP1T3TC5UACTIB
SUS SCROFA LUNG7GL3G1COB3ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PLANTAGO MAJOR WHOLEW2469WNO6UACTIB
ASPIDOSPERMA QUEBRACHO-BLANCO BARK52B1340190ACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
TOBACCO LEAF6YR2608RSUACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Nicotine FreeABIES NIGRA, ACONITUM NAPELLUS, AVENA SATIVA, CALADIUM SEGUINUM, IGNATIA AMARA, LOBELIA INFLATA, LUNG SUIS, NUX VOMICA, PLANTAGO MAJOR, QUEBRACHO, STICTA PULMONARIA, TABACUMLiddell Laboratories, Inc.11580c55-cfe8-42d5-b2f4-ab9141c380ad2024-11-04WarningsExact identifier
ndc (package): 50845-0267-1
ndc (product): 50845-0267
ndc11 (package): 50845026701
spl id: ff4e77d4-2a9e-4a5d-8c33-89c104ed8634
spl set id: 11580c55-cfe8-42d5-b2f4-ab9141c380ad

Reported adverse events (FAERS/openFDA)#

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