FDA.reportPublic FDA data

NDC 45802-957-01 - 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
45802-957
Requested NDC
45802-957-01
Package NDCs from labels
45802-957-01, 45802-957-02
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2026-08-27
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 Ltd2026-08-27HUMAN 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
45802-957-01Nicotine Polacrilex27 in 1 CONTAINERLOZENGE273
45802-957-02Nicotine Polacrilex3 in 1 CARTONLOZENGE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-957NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 2 package rows20250131_f6cc8d50-2d8d-4ed4-930a-a2479b1ebffe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-957-01EA - Each45802-95787ae052b-5a50-422c-8177-d36fa92b0e4512025-02-10

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 17 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXWalgreen Companydc1ffb6b-0865-4854-bbbd-97606995e3f42026-03-02WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.291649cf-e5a6-4a98-9a9e-c499b55c37ae2026-03-02WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
Focus, Comprehension and LearningAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, CALCAREA CARBONICA, IGNATIA AMARA, LECITHIN, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, OLEANDER, PHOSPHORICUM ACIDUM, RNA AND ZINCUM METALLICUM.King Bio Inc.b2a4dd82-7dd4-4dff-8a03-770f524bce1f2026-03-02WarningsExact identifier
unii: 45P3261C7T
NICOTINENICOTINE POLACRILEXWalgreen Company97fefc42-5c9d-453e-a0b6-dc7aac5ee8e12026-03-02WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Company74f306d4-2a71-48c9-ab98-378260507a9d2026-03-01WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNICOTINE POLACRILEXRugby Laboratoriesb973d045-7791-49c1-9216-4e0d511737352026-02-27WarningsExact identifier
unii: 6M3C89ZY6R
nicotine lozengeNICOTINE POLACRILEXH E Bdb78d030-7abf-494f-94ca-4a385f519faf2026-02-27WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXKroger Companyfd67cb75-509c-41d5-8a2c-6c5fc53bf5132026-02-26WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
HQLSEY QUIT SMOKING PATCHESQUIT SMOKING PATCHESHansen Pharmaceutical Investment Co., Limited4ba317fb-714a-05cb-e063-6394a90a382f2026-02-25WarningsExact identifier
unii: 6M3C89ZY6R
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc0eb7bd68-7260-404c-a928-7898c6c265722026-02-23WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex Coated FruitNICOTINE POLACRILEXPublix Supermarkets, Inc.c161e2d6-7691-4fd0-9f91-acfc336854202026-02-23WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex Coated MintNICOTINE POLACRILEXPublix Supermarkets, Inc.a6ef9fd0-9706-4924-b7f5-e2562b9d99e02026-02-23WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company7744ea8b-164a-4992-9874-a2b59bee585d2026-02-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex GumNICOTINE POLACRILEXFertin Pharma A/Sf1774540-7c2f-c60b-e053-2995a90a1ccb2026-02-18WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company788214db-3f78-4209-b3b6-d59cc9be34212026-02-18WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXA-S Medication Solutions83b3b56e-0081-41df-818c-bccc4a996b7f2026-02-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXKroger Company965be729-d417-4ae6-a2a9-ed06c2287d422026-02-17WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c2026-02-16WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXThe Kroger Co.f801e8b2-b789-41f4-b35e-ea3a82d2bb9c2026-02-13WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC17cf8f3d-6491-4cd8-a447-3c7533f76daf2026-02-13WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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