good sense nicotine

Generic: nicotine polacrilex

Labeler: l. perrigo company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name good sense nicotine
Generic Name nicotine polacrilex
Labeler l. perrigo company
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
L. Perrigo Company

Identifiers & Regulatory

Product NDC 0113-0957
Product ID 0113-0957_b5ee8512-cf07-4d90-b865-49e72ee8cf29
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203690
Listing Expiration 2026-12-31
Marketing Start 2013-04-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01130957
Hyphenated Format 0113-0957

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 good sense 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
  • 3 CONTAINER in 1 CARTON (0113-0957-02) / 27 LOZENGE in 1 CONTAINER (0113-0957-01)
  • 5 CONTAINER in 1 CARTON (0113-0957-04) / 27 LOZENGE in 1 CONTAINER (0113-0957-01)
  • 8 CONTAINER in 1 CARTON (0113-0957-07) / 27 LOZENGE in 1 CONTAINER (0113-0957-01)
  • 1 CONTAINER in 1 CARTON (0113-0957-60) / 20 LOZENGE in 1 CONTAINER
source: ndc

Packages (4)

0113-0957-02 3 CONTAINER in 1 CARTON (0113-0957-02) / 27 LOZENGE in 1 CONTAINER (0113-0957-01) 0113-0957-04 5 CONTAINER in 1 CARTON (0113-0957-04) / 27 LOZENGE in 1 CONTAINER (0113-0957-01) 0113-0957-07 8 CONTAINER in 1 CARTON (0113-0957-07) / 27 LOZENGE in 1 CONTAINER (0113-0957-01) 0113-0957-60 1 CONTAINER in 1 CARTON (0113-0957-60) / 20 LOZENGE in 1 CONTAINER

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Good Sense Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b5ee8512-cf07-4d90-b865-49e72ee8cf29", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["359818"], "spl_set_id": ["1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["L. Perrigo Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CONTAINER in 1 CARTON (0113-0957-02)  / 27 LOZENGE in 1 CONTAINER (0113-0957-01)", "package_ndc": "0113-0957-02", "marketing_start_date": "20130427"}, {"sample": false, "description": "5 CONTAINER in 1 CARTON (0113-0957-04)  / 27 LOZENGE in 1 CONTAINER (0113-0957-01)", "package_ndc": "0113-0957-04", "marketing_start_date": "20240621"}, {"sample": false, "description": "8 CONTAINER in 1 CARTON (0113-0957-07)  / 27 LOZENGE in 1 CONTAINER (0113-0957-01)", "package_ndc": "0113-0957-07", "marketing_start_date": "20240621"}, {"sample": false, "description": "1 CONTAINER in 1 CARTON (0113-0957-60)  / 20 LOZENGE in 1 CONTAINER", "package_ndc": "0113-0957-60", "marketing_start_date": "20180327"}], "brand_name": "Good Sense Nicotine", "product_id": "0113-0957_b5ee8512-cf07-4d90-b865-49e72ee8cf29", "dosage_form": "LOZENGE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "0113-0957", "generic_name": "Nicotine Polacrilex", "labeler_name": "L. Perrigo Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Good Sense Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA203690", "marketing_category": "ANDA", "marketing_start_date": "20130427", "listing_expiration_date": "20261231"}