nicorette original

Generic: nicotine polacrilex

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicorette original
Generic Name nicotine polacrilex
Labeler haleon us holdings llc
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 2 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0157
Product ID 0135-0157_1f929250-cbfa-d6eb-e063-6394a90a7281
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA018612
Listing Expiration 2026-12-31
Marketing Start 2009-06-29

Pharmacologic Class

Established (EPC)
cholinergic nicotinic agonist [epc]
Chemical Structure
nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01350157
Hyphenated Format 0135-0157

Supplemental Identifiers

RxCUI
105071 209326 311975 314119
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nicorette original (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number NDA018612 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0135-0157-07) / 110 GUM, CHEWING in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (0135-0157-10) / 170 GUM, CHEWING in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (0135-0157-11) / 200 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (3)

0135-0157-07 1 BLISTER PACK in 1 CARTON (0135-0157-07) / 110 GUM, CHEWING in 1 BLISTER PACK 0135-0157-10 1 BLISTER PACK in 1 CARTON (0135-0157-10) / 170 GUM, CHEWING in 1 BLISTER PACK 0135-0157-11 1 BLISTER PACK in 1 CARTON (0135-0157-11) / 200 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Nicorette Original, Nicorette Mint, Nicorette Spearmint Burst, Nicorette Cinnamon Surge, Nicorette White Ice Mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1f929250-cbfa-d6eb-e063-6394a90a7281", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["105071", "209326", "311975", "314119"], "spl_set_id": ["673fd19f-69b3-4f73-b9b4-18b5f4cbf69c"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0135-0157-07)  / 110 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0135-0157-07", "marketing_start_date": "20090629"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0135-0157-10)  / 170 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0135-0157-10", "marketing_start_date": "20090629"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0135-0157-11)  / 200 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "0135-0157-11", "marketing_start_date": "20090629"}], "brand_name": "Nicorette Original", "product_id": "0135-0157_1f929250-cbfa-d6eb-e063-6394a90a7281", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0135-0157", "generic_name": "nicotine polacrilex", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicorette", "brand_name_suffix": "Original", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "NDA018612", "marketing_category": "NDA", "marketing_start_date": "20090629", "listing_expiration_date": "20261231"}