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 31 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodsense Fiber laxative 147CALCIUM POLYCARBOPHILGoodSense17f5570b-be85-9dce-e063-6294a90abeaf2025-01-14WarningsExact identifier
unii: 8F049NKY49
Nicotine PolacrilexNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltd157e5479-28d6-4493-a8cf-597b9e5622c02025-01-14WarningsExact identifier
unii: 6M3C89ZY6R
Calcium PolycarbophilCALCIUM POLYCARBOPHILSHANDONG XINHUA PHARMACEUTICAL CO., LTD.ee06868b-f741-8da2-e053-2a95a90a97722025-01-02WarningsExact identifier
unii: 8F049NKY49
EsteemAGNUS CASTUS, AMBRA GRISEA, ANACARDIUM ORIENTALE, AURUM METALLICUM, BARYTA IODATA, CANDIDA ALBICANS, CARCINOSIN, CUBEBA OFFICINALIS, HYPOTHALAMUS SUIS, LAC CANINUM, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, MAGNESIUM IODIDE, NAJA TRIPUDIANS, NATRUM CARBONICUM, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, THUJA OCCIDENTALIS, VISCUM ALBUMDeseret Biologicals, Inc.f10cebe6-6ed1-45f7-80d4-f6c19fd8d0942024-12-30WarningsExact identifier
unii: 45P3261C7T
Nicorette Fruit Chill nicotine polacrilexNICOTINELil' Drug Store Products, Inc.01db011d-924c-40e4-bd5d-44eb267b8de12024-12-30WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette White Mint nicotine polacrilexNICOTINELil' Drug Store Products, Inc.4aec3330-411e-415f-a505-3ab7fa7295bb2024-12-30WarningsExact identifier
unii: 6M3C89ZY6R
Fiber TherapyCALCIUM POLYCARBOPHILWal-Mart Stores, Inc.3432a4a6-aeb1-4a72-8451-5903266931fa2024-12-20WarningsExact identifier
unii: 8F049NKY49
Fiber LaxativeCALCIUM POLYCARBOPHILUNITED NATURAL FOODS, INC. DBA UNFIf7236bbc-8ded-4e11-8cce-b0a2255e14502024-12-20WarningsExact identifier
unii: 8F049NKY49
Fiber CapsCALCIUM POLYCARBOPHILGuardian Drug Company31e6b0c7-1d4a-4660-ae87-9d18e0001dcd2024-12-19WarningsExact identifier
unii: 8F049NKY49
Nicotine PolacrilexNICOTINE POLACRILEXQuitine LLCdc142c50-5310-43f5-a9e5-e174116685f82024-12-17WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXQuitine LLC9e46b967-1668-42a7-be87-225ded8493952024-12-17WarningsExact identifier
unii: 6M3C89ZY6R
Foster and Thrive Fiber Laxative 147CALCIUM POLYCARBOPHILStrategic Sourcing Services LLC88d341a6-28aa-4a20-bfed-1d5f3106c2ae2024-12-12WarningsExact identifier
unii: 8F049NKY49
Nicotine transdermal system step 3NICOTINECVS Pharmacyd51d5224-f5bf-2510-1fa0-c4bb454f81602024-12-01WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMCardinal Healthc4cc8321-807f-258f-71f5-e993f633f9e32024-11-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal system step 3NICOTINEStrategic Sourcing Services LLC6c0b5b5c-cc76-6e48-c364-4db0e081557d2024-11-09WarningsExact identifier
unii: 6M3C89ZY6R
Rite Aid Fiber CapletsCALCIUM POLYCARBOPHILRITE AID CORPORATION06e46cb0-2928-479e-984d-2305fff995e02024-10-30WarningsExact identifier
unii: 8F049NKY49
Premier ValueCALCIUM POLYCARBOPHILPHARMACY VALUE ALLIANCE, LLC4d766548-00d0-41bd-bb58-b69e037c77e22024-10-28WarningsExact identifier
unii: 8F049NKY49
ProgeniteAMMONIUM CARBONICUM, BARYTA MURIATICA, BORAX, CAULOPHYLLUM THALICTROIDES, NATRUM CARBONICUM, SABAL SERRULATA, SABINA, SULPHURICUM ACIDUM, THIOSINAMINUM, FOLLICULINUM, TUBA UTERINA SUIS, UTERUS SUIS, HYPOTHALAMUS (SUIS), THYROIDINUM (SUIS), AGNUS CASTUS, CONIUM MACULATUM, GRAPHITES, HYOSCYAMUS NIGER, SEPIA, SELENIUM METALLICUM, X-RAYDeseret Biologicalsdfc114e0-34d4-4ae4-bba8-a8a1b7ad6a242024-10-23WarningsExact identifier
unii: 45P3261C7T
EsteemAMBRA GRISEA, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, VISCUM ALBUM, THUJA OCCIDENTALIS, HYPOTHALAMUS SUIS, CUBEBA OFFICINALIS, AGNUS CASTUS, ANACARDIUM ORIENTALE, BARYTA IODATA, LAC CANINUM, NAJA TRIPUDIANS, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, AURUM METALLICUM, LAC FELINUM, MAGNESIUM IODIDE, CARCINOSINDeseret Biologicals, Inc.2946e748-85a9-4398-b4b6-81aa0f3ebe692024-10-04WarningsExact identifier
unii: 45P3261C7T
Nicotine Polacrilex coated ice mintNICOTINE POLACRILEXCVS Pharmacye4e3fd5f-1ed1-4a18-9c31-7224cae77ded2024-10-03WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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