Nicotine Polacrilex Original Flavor

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 Original Flavor
Generic name: NICOTINE POLACRILEX
Manufacturer: Publix Supermarkets, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 540c88bd-70dc-416a-8d8e-0a33b2b29563
SPL ID: 35b42ef4-7ba7-45e0-b2ba-a47915781e04
Version: 15
Effective date: 2026-09-02
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:56:44

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 · 19 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	074707	derived:openfda.application_number
application applno	ANDA	074507	derived:openfda.application_number
application number		ANDA074707	openfda.application_number
application number		ANDA074507	openfda.application_number
brand name		Nicotine Polacrilex Origianl Flavor	openfda.brand_name
brand name		Nicotine Polacrilex Original Flavor	openfda.brand_name
generic name		NICOTINE POLACRILEX	openfda.generic_name
manufacturer name		Publix Supermarkets, Inc.	openfda.manufacturer_name
ndc	package	56062-608-62	openfda.package_ndc
ndc	package	56062-609-62	openfda.package_ndc
ndc	product	56062-609	openfda.product_ndc
ndc	product	56062-608	openfda.product_ndc
ndc11	package	56062060962	derived:openfda.package_ndc
ndc11	package	56062060862	derived:openfda.package_ndc
rxcui		314119	openfda.rxcui
rxcui		311975	openfda.rxcui
spl id		35b42ef4-7ba7-45e0-b2ba-a47915781e04	id
spl set id		540c88bd-70dc-416a-8d8e-0a33b2b29563	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.