FDA.reportPublic FDA data

NDC 45802-089-01 - Nicotine Polacrilex

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
45802-089
Requested NDC
45802-089-01
Package NDCs from labels
45802-089-01, 45802-089-02
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2026-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2026-04-30HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch PrepackBryant Ranch Prepack2025-07-29HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch PrepackBryant Ranch Prepack2025-04-03HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-089-01Nicotine Polacrilex27 in 1 CONTAINERLOZENGE274
45802-089-02Nicotine Polacrilex3 in 1 CARTONLOZENGE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-089NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 2 package rows20250228_b765570e-e5b5-48e4-b4d2-2a85ac19a2ea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-089-01EA - Each45802-0892761a663-9f19-4540-8d44-12ddfad2eee412026-05-22

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oneoo Nicotine Gum (Mint)NICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.54b1329b-b422-29a5-e063-6294a90a87802026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXP & L Development, LLC3623455a-3f00-41d3-b17e-86a016da70472026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC10e3e1ac-2f78-4ce4-8f38-a283fac996602026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecd78195-2df2-401d-b590-2c1cb764df5c2026-08-05WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf97d6b-6ca7-48c1-8c37-029421689cc12026-08-05WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS Pharmacycb9189d6-0593-426d-8ff5-357a4c9180f62026-08-05WarningsExact identifier
unii: 6M3C89ZY6R
good sense nicotineNICOTINE POLACRILEXL. Perrigo Companyeefcb8f8-4334-4e75-8e52-ef1ffbf3f0a92026-08-04WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLC634e50f9-92bb-43be-bd90-360d67d174eb2026-08-04WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC48230756-9448-4957-82a6-5e7e3c2c0b572026-08-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AID Step1NICOTINE 21 MGGuangxi Keyun E-commerce Co., Ltd.57a7a614-5f23-258b-e063-6294a90a94b12026-07-28WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AID Step2NICOTINE 14 MGGuangxi Keyun E-commerce Co., Ltd.57a8a71b-7213-ab7d-e063-6394a90a51302026-07-28WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AID Step3NICOTINE 7 MGGuangxi Keyun E-commerce Co., Ltd.57a8b8d3-0acc-bf91-e063-6294a90a99f82026-07-28WarningsExact identifier
unii: 6M3C89ZY6R
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
unii: 6M3C89ZY6R
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporationcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b2026-07-24WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc4ddba70a-3f45-4c76-a12a-6da256e9afc52026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCc6c9582c-004d-4925-b147-add5f28f38562026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS Pharmacyab1407e3-9092-438c-b684-8194e4ee71af2026-07-23WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Up and Up NicotineNICOTINE POLACRILEXTarget Corporationa4bf013b-286b-486c-bb8f-2defb3881d4c2026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Incecdfe02c-813b-4c1e-9e02-d7c544a896442026-07-23WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.