nicotine polacrilex coated ice mint (69842-216)

Drug Facts

Product Profile

Brand Name nicotine polacrilex coated ice mint

Generic Name nicotine polacrilex

Labeler cvs pharmacy

Dosage Form GUM, CHEWING

Routes

BUCCAL

Active Ingredients

nicotine 2 mg/1

Manufacturer

CVS Pharmacy

Identifiers & Regulatory

Product NDC 69842-216

Product ID 69842-216_5f0324e3-b546-4cdc-af4d-e45e2052a179

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA204794

Listing Expiration 2026-12-31

Marketing Start 2016-05-01

Pharmacologic Class

Established (EPC)

cholinergic nicotinic agonist [epc]

Chemical Structure

nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69842216

Hyphenated Format 69842-216

Supplemental Identifiers

RxCUI

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 nicotine polacrilex coated ice mint (source: ndc)

Generic Name nicotine polacrilex (source: ndc)

Application Number ANDA204794 (source: ndc)

Routes

BUCCAL

source: ndc

Resolved Composition

Strengths

2 mg/1

source: ndc

Packaging

20 BLISTER PACK in 1 CARTON (69842-216-15) / 1 GUM, CHEWING in 1 BLISTER PACK
160 BLISTER PACK in 1 CARTON (69842-216-16) / 1 GUM, CHEWING in 1 BLISTER PACK
100 BLISTER PACK in 1 CARTON (69842-216-44) / 1 GUM, CHEWING in 1 BLISTER PACK

source: ndc

Packages (3)

69842-216-15 20 BLISTER PACK in 1 CARTON (69842-216-15) / 1 GUM, CHEWING in 1 BLISTER PACK 69842-216-16 160 BLISTER PACK in 1 CARTON (69842-216-16) / 1 GUM, CHEWING in 1 BLISTER PACK 69842-216-44 100 BLISTER PACK in 1 CARTON (69842-216-44) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (2 mg/1)

Linked Drug Pages (1)

Nicotine Polacrilex coated ice mint ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["BUCCAL"], "spl_id": "5f0324e3-b546-4cdc-af4d-e45e2052a179", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975", "314119"], "spl_set_id": ["e4e3fd5f-1ed1-4a18-9c31-7224cae77ded"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["CVS Pharmacy"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (69842-216-15)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "69842-216-15", "marketing_start_date": "20160501"}, {"sample": false, "description": "160 BLISTER PACK in 1 CARTON (69842-216-16)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "69842-216-16", "marketing_start_date": "20160501"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (69842-216-44)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "69842-216-44", "marketing_start_date": "20160501"}], "brand_name": "Nicotine Polacrilex coated ice mint", "product_id": "69842-216_5f0324e3-b546-4cdc-af4d-e45e2052a179", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "69842-216", "generic_name": "Nicotine Polacrilex", "labeler_name": "CVS Pharmacy", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine Polacrilex", "brand_name_suffix": "coated ice mint", "active_ingredients": [{"name": "NICOTINE", "strength": "2 mg/1"}], "application_number": "ANDA204794", "marketing_category": "ANDA", "marketing_start_date": "20160501", "listing_expiration_date": "20261231"}