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 16 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINE TRANSDERMAL SYSTEMNICOTINEA-S Medication Solutionscfb56e3e-ac5d-4086-a5d3-23080844b3e12026-03-13WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXWalgreensfe5c4bfd-a792-4923-b2db-16be44d599ea2026-03-12WarningsExact identifier
unii: 6M3C89ZY6R
FiberconCALCIUM POLYCARBOPHILFoundation Consumer Brands7992a4bb-5535-4a1d-867d-a99f7e0c1be72026-03-12WarningsExact identifier
unii: 8F049NKY49
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612239640129-2d7a-4ec5-81a1-e14b11d3d3ee2026-03-12WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E Bb1a13942-1fad-40da-8664-f70574b950d72026-03-11WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXHyVee Incb9257174-fbd4-453d-aa23-77d5a8f91b892026-03-11WarningsExact identifier
unii: 6M3C89ZY6R
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: 45P3261C7T
Gout Symptom ReliefAMMON PHOS, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA AND URTICA URENS.King Bio Inc.41dc03fc-169b-4691-bd62-9a41d7a6d2f72026-03-06WarningsExact identifier
unii: 45P3261C7T
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMH-E-Bda35e19d-b0aa-8a5f-140e-7601bd2027fe2026-03-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMTopco Associates LLCa631d31d-38e6-1772-8b6d-57672b785d982026-03-06WarningsExact identifier
unii: 6M3C89ZY6R
BEST SMELLING SALTSAMMONIUM CHLORIDE, SODIUM CARBONATE INHALANTHyvia Health LLC4c5cde0c-1de7-ce67-e063-6394a90a95792026-03-06WarningsExact identifier
unii: 45P3261C7T
Good Mood EnhancerAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SEPIA, SINAPIS ARVENSIS, FLOS AND TABACUM.King Bio Inc.26150aa1-7729-4f64-a761-eab251f046e52026-03-06WarningsExact identifier
unii: 45P3261C7T
PneumoforceALTHAEA OFFICINALIS, NATRUM CARBONICUM, RHEUM (PALMATUM), VERBASCUM THAPSUS, ZINGIBER OFFICINALE, ACONITUM NAPELLUS, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, LOBELIA INFLATA, PHOSPHORUSBioActive Nutritional, Inc.a58c6a1a-ad3e-4055-8077-b6738105087d2026-03-05WarningsExact identifier
unii: 45P3261C7T
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: 45P3261C7T
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc049d2c75-9b7f-4248-81e9-e2973a4cab5d2026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEH E B85e3a322-e1a2-4f8e-a616-b279ad1bcefe2026-03-03WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Companye5a8974f-d402-4390-8b80-b896b094a0592026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEH E Bbe4a13e4-9938-4223-bcc1-4f5d969728132026-03-03WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B1fb02f5e-56af-47ef-a1bc-49a6d86cc70c2026-03-03WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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