rexall nicotine

Generic: nicotine polacrilex

Labeler: dolgencorp, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rexall nicotine
Generic Name nicotine polacrilex
Labeler dolgencorp, llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
Dolgencorp, LLC

Identifiers & Regulatory

Product NDC 55910-957
Product ID 55910-957_b1a961d6-357a-415e-94f2-a063b3021943
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203690
Listing Expiration 2026-12-31
Marketing Start 2013-08-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55910957
Hyphenated Format 55910-957

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 rexall 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
  • 1 CONTAINER in 1 CARTON (55910-957-60) / 20 LOZENGE in 1 CONTAINER
source: ndc

Packages (1)

55910-957-60 1 CONTAINER in 1 CARTON (55910-957-60) / 20 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Rexall Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b1a961d6-357a-415e-94f2-a063b3021943", "openfda": {"nui": ["N0000175706", "M0014836"], "upc": ["0012345678905"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["83b053f6-304b-4f9c-8a6d-6649998708b2"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Dolgencorp, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (55910-957-60)  / 20 LOZENGE in 1 CONTAINER", "package_ndc": "55910-957-60", "marketing_start_date": "20130808"}], "brand_name": "Rexall Nicotine", "product_id": "55910-957_b1a961d6-357a-415e-94f2-a063b3021943", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "55910-957", "generic_name": "Nicotine Polacrilex", "labeler_name": "Dolgencorp, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rexall Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA203690", "marketing_category": "ANDA", "marketing_start_date": "20130808", "listing_expiration_date": "20261231"}