nicotine

Generic: nicotine polacrilex

Labeler: h e b
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine
Generic Name nicotine polacrilex
Labeler h e b
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
H E B

Identifiers & Regulatory

Product NDC 37808-563
Product ID 37808-563_1fb02f5e-56af-47ef-a1bc-49a6d86cc70c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203690
Listing Expiration 2026-12-31
Marketing Start 2019-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 37808563
Hyphenated Format 37808-563

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 ANDA203690 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 4 CONTAINER in 1 CARTON (37808-563-10) / 27 LOZENGE in 1 CONTAINER
source: ndc

Packages (1)

37808-563-10 4 CONTAINER in 1 CARTON (37808-563-10) / 27 LOZENGE in 1 CONTAINER

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": "1fb02f5e-56af-47ef-a1bc-49a6d86cc70c", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["1fb02f5e-56af-47ef-a1bc-49a6d86cc70c"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 CONTAINER in 1 CARTON (37808-563-10)  / 27 LOZENGE in 1 CONTAINER", "package_ndc": "37808-563-10", "marketing_start_date": "20190401"}], "brand_name": "nicotine", "product_id": "37808-563_1fb02f5e-56af-47ef-a1bc-49a6d86cc70c", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "37808-563", "generic_name": "Nicotine Polacrilex", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA203690", "marketing_category": "ANDA", "marketing_start_date": "20190401", "listing_expiration_date": "20261231"}