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 19 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXWalgreens902c6ae5-971b-427c-b311-5a051b98a53d2026-02-03WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotine polacrilexNICOTINEH E Bd1f1453d-75a8-4c54-a28a-fb631db54ba42026-02-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXMeijer Distribution Incb451316e-6c78-4156-ad28-c10166deec792026-01-29WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXCVS Pharmacy89e2a6b9-e759-4c18-a04d-d6fc9f2645752026-01-29WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXMeijer Distribution Inc6d86cb8f-018e-41be-a6d0-9ca30e7318552026-01-29WarningsExact identifier
unii: 6M3C89ZY6R
Sielkin QUIT SMOKING NICOTINE PATCHES 14mgNICOTINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD29b55f67-503f-cf96-e063-6294a90a5f652026-01-28WarningsExact identifier
unii: 6M3C89ZY6R
Sielkin QUIT SMOKING NICOTINE PATCHESNICOTINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD2969f3cc-8e45-f93d-e063-6294a90a93ad2026-01-28WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXMeijer Distribution Inc886c594f-4ff6-46e1-a992-cc6ec033db3a2026-01-27WarningsExact identifier
unii: 6M3C89ZY6R
Flobow QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD495b10ce-3d2d-1aa4-e063-6294a90a4f352026-01-27WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXNuCare Pharmaceuticals, Inc.49125b9b-8ccd-b122-e063-6394a90a483c2026-01-27WarningsExact identifier
unii: 6M3C89ZY6R
Sielkin QUIT SMOKING NICOTINE PATCHES 21mgNICOTINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD29b6287b-3ce3-e446-e063-6294a90a163b2026-01-27WarningsExact identifier
unii: 6M3C89ZY6R
Calcium PolycarbophilCALCIUM POLYCARBOPHILCVS Pharmacy, Incc3de1c1b-5042-aec3-e053-2a95a90ad1342026-01-27WarningsExact identifier
unii: 8F049NKY49
Nicotine Sugar FreeNICOTINE POLACRILEXCVS Pharmacy9a96ba38-e696-4465-9869-9b269dc18f8d2026-01-27WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXMeijer, Inc.2da4cfb9-2b8d-4465-adf5-edd52671b9fc2026-01-27WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXMeijer, Inc.a6618365-8483-4a40-b81f-4d581b1743722026-01-27WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Nicotine transdermal systemNICOTINEWal-Mart Stores Incaefd30c4-35d5-425e-855c-327a7c4361882026-01-26WarningsExact identifier
unii: 6M3C89ZY6R
GOOD SENSE NICOTINENICOTINE POLACRILEXL. Perrigo Company8823c7a9-22b3-492b-b72d-70e7cb1a3f472026-01-26WarningsExact identifier
unii: 6M3C89ZY6R
QUIT SMOKING 14mgQUIT SMOKING 14MGShenzhen Hengdasheng Technology Co., Ltd48f9362e-7dfc-eded-e063-6394a90aae5c2026-01-22WarningsExact identifier
unii: 6M3C89ZY6R
QUIT SMOKING 21mgQUIT SMOKING 21MGShenzhen Hengdasheng Technology Co., Ltd48f9ca37-00e6-c725-e063-6294a90ae1af2026-01-22WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEMeijer, Inc.78b85047-b412-44fa-91e1-a1c891d478762026-01-22WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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