care one nicotine

Generic: nicotine polacrilex

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name care one nicotine
Generic Name nicotine polacrilex
Labeler american sales company
Dosage Form GUM, CHEWING
Routes
ORAL
Active Ingredients

nicotine 4 mg/1

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-854
Product ID 41520-854_e82e1e11-e72f-493e-8863-b1347b301008
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078546
Listing Expiration 2026-12-31
Marketing Start 2008-07-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 41520854
Hyphenated Format 41520-854

Supplemental Identifiers

RxCUI
311975
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 care one nicotine (source: ndc)
Generic Name nicotine polacrilex (source: ndc)
Application Number ANDA078546 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (41520-854-78) / 1 GUM, CHEWING in 1 BLISTER PACK
source: ndc

Packages (1)

41520-854-78 100 BLISTER PACK in 1 CARTON (41520-854-78) / 1 GUM, CHEWING in 1 BLISTER PACK

Ingredients (1)

nicotine (4 mg/1)

Linked Drug Pages (1)

Care One Nicotine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e82e1e11-e72f-493e-8863-b1347b301008", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["311975"], "spl_set_id": ["78cf8b14-cdad-464c-afb5-9fc49ebc3921"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (41520-854-78)  / 1 GUM, CHEWING in 1 BLISTER PACK", "package_ndc": "41520-854-78", "marketing_start_date": "20080725"}], "brand_name": "Care One Nicotine", "product_id": "41520-854_e82e1e11-e72f-493e-8863-b1347b301008", "dosage_form": "GUM, CHEWING", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "41520-854", "generic_name": "Nicotine polacrilex", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Care One Nicotine", "active_ingredients": [{"name": "NICOTINE", "strength": "4 mg/1"}], "application_number": "ANDA078546", "marketing_category": "ANDA", "marketing_start_date": "20080725", "listing_expiration_date": "20261231"}