Nicotine

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Nicotine
Generic name: NICOTINE POLACRILEX
Manufacturer: Cardinal Health 107, LLC
Product type: HUMAN OTC DRUG
SPL set ID: ebab2c3a-4fda-40d6-8f54-972e1c6ee69a
SPL ID: ebab2c3a-4fda-40d6-8f54-972e1c6ee69a
Version: 1
Effective date: 2026-08-24
Source export date: 2026-10-30
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/9dea423b9e87a781c152bc6e136923fb91acb0732a7a0ec0d2a51142148f160c/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:44:16

Harmonized routes table
Harmonized routes
BUCCAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	076569	derived:openfda.application_number
application number		ANDA076569	openfda.application_number
brand name		Nicotine	openfda.brand_name
generic name		NICOTINE POLACRILEX	openfda.generic_name
manufacturer name		Cardinal Health 107, LLC	openfda.manufacturer_name
ndc	package	55154-6818-0	openfda.package_ndc
ndc	product	55154-6818	openfda.product_ndc
ndc11	package	55154681800	derived:openfda.package_ndc
rxcui		314119	openfda.rxcui
spl id		ebab2c3a-4fda-40d6-8f54-972e1c6ee69a	id
spl set id		ebab2c3a-4fda-40d6-8f54-972e1c6ee69a	set_id
unii		6M3C89ZY6R	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Reported adverse events (FAERS/openFDA)#

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