Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit

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: Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit
Generic name: NICOTINE POLACRILEX
Manufacturer: Dr. Reddy's Laboratories Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 5d3b45d6-97c2-4400-ad09-95a4b21f5324
SPL ID: a4527ea5-aaa6-4b69-8420-bcf930ed2090
Version: 10
Effective date: 2025-12-23
Source export date: 2026-10-27
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/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:48:56

Harmonized routes table
Harmonized routes
ORAL

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	079038	derived:openfda.application_number
application number		ANDA079038	openfda.application_number
brand name		Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit	openfda.brand_name
generic name		NICOTINE POLACRILEX	openfda.generic_name
manufacturer name		Dr. Reddy's Laboratories Inc.	openfda.manufacturer_name
ndc	package	75907-300-80	openfda.package_ndc
ndc	package	75907-300-15	openfda.package_ndc
ndc	package	75907-300-10	openfda.package_ndc
ndc	product	75907-300	openfda.product_ndc
ndc11	package	75907030080	derived:openfda.package_ndc
ndc11	package	75907030015	derived:openfda.package_ndc
ndc11	package	75907030010	derived:openfda.package_ndc
rxcui		2717264	openfda.rxcui
rxcui		311975	openfda.rxcui
spl id		a4527ea5-aaa6-4b69-8420-bcf930ed2090	id
spl set id		5d3b45d6-97c2-4400-ad09-95a4b21f5324	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.