nicotine

Generic: nicotine polacrilex

Labeler: cvs pharmacy
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler cvs pharmacy
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
CVS Pharmacy

Identifiers & Regulatory

Product NDC 69842-564
Product ID 69842-564_da20b0a7-14b7-49eb-90c7-86cc890aff8b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207868
Listing Expiration 2026-12-31
Marketing Start 2020-05-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69842564
Hyphenated Format 69842-564

Supplemental Identifiers

RxCUI
359818
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 (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA207868 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (69842-564-10) / 10 LOZENGE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (69842-564-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (69842-564-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC
  • 5 BOTTLE, PLASTIC in 1 BOX (69842-564-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC
  • 3 BOTTLE, PLASTIC in 1 BOX (69842-564-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC
source: ndc

Packages (5)

69842-564-10 1 BOTTLE, PLASTIC in 1 BOX (69842-564-10) / 10 LOZENGE in 1 BOTTLE, PLASTIC 69842-564-20 1 BOTTLE, PLASTIC in 1 BOX (69842-564-20) / 20 LOZENGE in 1 BOTTLE, PLASTIC 69842-564-27 1 BOTTLE, PLASTIC in 1 BOX (69842-564-27) / 27 LOZENGE in 1 BOTTLE, PLASTIC 69842-564-35 5 BOTTLE, PLASTIC in 1 BOX (69842-564-35) / 27 LOZENGE in 1 BOTTLE, PLASTIC 69842-564-81 3 BOTTLE, PLASTIC in 1 BOX (69842-564-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "da20b0a7-14b7-49eb-90c7-86cc890aff8b", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["7fa848c6-3a4a-41f3-b927-1b26b6232e3a"], "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": "1 BOTTLE, PLASTIC in 1 BOX (69842-564-10)  / 10 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "69842-564-10", "marketing_start_date": "20200529"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (69842-564-20)  / 20 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "69842-564-20", "marketing_start_date": "20200529"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (69842-564-27)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "69842-564-27", "marketing_start_date": "20200529"}, {"sample": false, "description": "5 BOTTLE, PLASTIC in 1 BOX (69842-564-35)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "69842-564-35", "marketing_start_date": "20200529"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (69842-564-81)  / 27 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "69842-564-81", "marketing_start_date": "20200529"}], "brand_name": "Nicotine", "product_id": "69842-564_da20b0a7-14b7-49eb-90c7-86cc890aff8b", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "69842-564", "generic_name": "Nicotine Polacrilex", "labeler_name": "CVS Pharmacy", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA207868", "marketing_category": "ANDA", "marketing_start_date": "20200529", "listing_expiration_date": "20261231"}