nicotine mini

Generic: nicotine polacrilex

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine mini
Generic Name nicotine polacrilex
Labeler rising pharma holdings, inc.
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-321
Product ID 57237-321_02faa0ad-b311-4bfa-9e0f-b085939d7063
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207868
Listing Expiration 2026-12-31
Marketing Start 2023-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57237321
Hyphenated Format 57237-321

Supplemental Identifiers

RxCUI
359817 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 mini (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 (57237-321-42) / 24 LOZENGE in 1 BOTTLE, PLASTIC
  • 3 BOTTLE, PLASTIC in 1 BOX (57237-321-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC
  • 3 BOTTLE, PLASTIC in 1 BOX (57237-321-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC (57237-321-27)
source: ndc

Packages (3)

57237-321-42 1 BOTTLE, PLASTIC in 1 BOX (57237-321-42) / 24 LOZENGE in 1 BOTTLE, PLASTIC 57237-321-72 3 BOTTLE, PLASTIC in 1 BOX (57237-321-72) / 24 LOZENGE in 1 BOTTLE, PLASTIC 57237-321-81 3 BOTTLE, PLASTIC in 1 BOX (57237-321-81) / 27 LOZENGE in 1 BOTTLE, PLASTIC (57237-321-27)

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Nicotine Mini ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02faa0ad-b311-4bfa-9e0f-b085939d7063", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359817", "359818"], "spl_set_id": ["05990040-5bd7-4622-8fe3-2d7573904dfa"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (57237-321-42)  / 24 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "57237-321-42", "marketing_start_date": "20230810"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (57237-321-72)  / 24 LOZENGE in 1 BOTTLE, PLASTIC", "package_ndc": "57237-321-72", "marketing_start_date": "20230810"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (57237-321-81)  / 27 LOZENGE in 1 BOTTLE, PLASTIC (57237-321-27)", "package_ndc": "57237-321-81", "marketing_start_date": "20251208"}], "brand_name": "Nicotine Mini", "product_id": "57237-321_02faa0ad-b311-4bfa-9e0f-b085939d7063", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "57237-321", "generic_name": "nicotine polacrilex", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "brand_name_suffix": "Mini", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA207868", "marketing_category": "ANDA", "marketing_start_date": "20230810", "listing_expiration_date": "20261231"}