Rugby Nicotine Polacrilex Gum, Coated Fruit 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: Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor
Generic name: NICOTINE POLACRILEX
Manufacturer: Rugby Laboratories
Product type: HUMAN OTC DRUG
SPL set ID: b973d045-7791-49c1-9216-4e0d51173735
SPL ID: c3233d63-7235-4d38-bea1-e0f2d0fe9cd1
Version: 18
Effective date: 2026-02-27
Source export date: 2026-10-27
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:14:37

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 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	079044	derived:openfda.application_number
application applno	ANDA	079038	derived:openfda.application_number
application number		ANDA079044	openfda.application_number
application number		ANDA079038	openfda.application_number
brand name		Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor	openfda.brand_name
generic name		NICOTINE POLACRILEX	openfda.generic_name
manufacturer name		Rugby Laboratories	openfda.manufacturer_name
ndc	package	0536-3387-37	openfda.package_ndc
ndc	package	0536-3386-37	openfda.package_ndc
ndc	package	0536-3387-01	openfda.package_ndc
ndc	package	0536-3386-01	openfda.package_ndc
ndc	product	0536-3386	openfda.product_ndc
ndc	product	0536-3387	openfda.product_ndc
ndc11	package	00536338601	derived:openfda.package_ndc
ndc11	package	00536338637	derived:openfda.package_ndc
ndc11	package	00536338737	derived:openfda.package_ndc
ndc11	package	00536338701	derived:openfda.package_ndc
rxcui		314119	openfda.rxcui
rxcui		311975	openfda.rxcui
spl id		c3233d63-7235-4d38-bea1-e0f2d0fe9cd1	id
spl set id		b973d045-7791-49c1-9216-4e0d51173735	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.