Nicotine Polacrilex Coated Mint

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 Polacrilex Coated Mint
Generic name: NICOTINE POLACRILEX
Manufacturer: CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Product type: HUMAN OTC DRUG
SPL set ID: 2c420ee4-0ed0-4a3f-bc92-202d825d0ca3
SPL ID: 7b8f2279-83c7-4b39-bf76-ca081ba91b25
Version: 17
Effective date: 2026-04-13
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:45:50

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 · 18 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	078699	derived:openfda.application_number
application applno	ANDA	078697	derived:openfda.application_number
application number		ANDA078697	openfda.application_number
application number		ANDA078699	openfda.application_number
brand name		Nicotine Polacrilex Coated Mint	openfda.brand_name
generic name		NICOTINE POLACRILEX	openfda.generic_name
manufacturer name		CARDINAL HEALTH 110, LLC. DBA LEADER 70000	openfda.manufacturer_name
ndc	package	70000-0347-1	openfda.package_ndc
ndc	package	70000-0343-1	openfda.package_ndc
ndc	product	70000-0343	openfda.product_ndc
ndc	product	70000-0347	openfda.product_ndc
ndc11	package	70000034701	derived:openfda.package_ndc
ndc11	package	70000034301	derived:openfda.package_ndc
rxcui		314119	openfda.rxcui
rxcui		311975	openfda.rxcui
spl id		7b8f2279-83c7-4b39-bf76-ca081ba91b25	id
spl set id		2c420ee4-0ed0-4a3f-bc92-202d825d0ca3	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.