nicotine

Generic: nicotine polacrilex

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler cvs woonsocket prescription center, incorporated
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-190
Product ID 51316-190_6e653b9b-5e39-4a91-bdea-3da5ee7ef0a2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090711
Listing Expiration 2026-12-31
Marketing Start 2024-06-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316190
Hyphenated Format 51316-190

Supplemental Identifiers

RxCUI
359818
UPC
0012345678905
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 ANDA090711 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 4 CONTAINER in 1 CARTON (51316-190-10) / 27 LOZENGE in 1 CONTAINER (51316-190-09)
source: ndc

Packages (1)

51316-190-10 4 CONTAINER in 1 CARTON (51316-190-10) / 27 LOZENGE in 1 CONTAINER (51316-190-09)

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": "6e653b9b-5e39-4a91-bdea-3da5ee7ef0a2", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["114418c4-6f39-46ce-912c-ac3687b7b75e"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 CONTAINER in 1 CARTON (51316-190-10)  / 27 LOZENGE in 1 CONTAINER (51316-190-09)", "package_ndc": "51316-190-10", "marketing_start_date": "20240619"}], "brand_name": "NICOTINE", "product_id": "51316-190_6e653b9b-5e39-4a91-bdea-3da5ee7ef0a2", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "51316-190", "generic_name": "Nicotine Polacrilex", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NICOTINE", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA090711", "marketing_category": "ANDA", "marketing_start_date": "20240619", "listing_expiration_date": "20261231"}