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 33 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINERugby Laboratories2dd4cbda-5c46-4655-b69d-21b7d2e912cf2024-06-05WarningsExact identifier
unii: 6M3C89ZY6R
good sense nicotineNICOTINE POLACRILEXA-S Medication Solutionsaf4323b6-5240-4697-992a-512c4d0983402024-05-15WarningsExact identifier
unii: 6M3C89ZY6R
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: 45P3261C7T
nicotineNICOTINE POLACRILEXCVS Pharmacya7348e93-bc5d-48d8-b2a4-daf921343d442024-05-08WarningsExact identifier
unii: 6M3C89ZY6R
up and up cherry nicotineNICOTINE POLACRILEXTarget Corporation85d82812-9f90-401f-8a2c-729cbfdf4c782024-03-29WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
up and up mint nicotineNICOTINE POLACRILEXTarget Corporation740833d6-5406-4609-9d14-bd5c9072fe9a2024-03-28WarningsExact identifier
unii: 6M3C89ZY6R
up and up mint nicotineNICOTINE POLACRILEXTarget Corporationcf7e3e9d-ec46-49de-b760-63d89c67823a2024-03-28WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
EdemaELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR.Newton Laboratories, Inc.14957500-1b2a-8427-e063-6394a90a371a2024-03-26WarningsExact identifier
unii: 45P3261C7T
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLC991704ed-781a-489b-8b56-0b558e8fc3852024-03-21WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Edema - Fluid RetentionELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR.Newton Laboratories, Inc.14077bb2-9c51-0139-e063-6394a90a49642024-03-19WarningsExact identifier
unii: 45P3261C7T
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.7e3a254b-a43d-43a2-a777-0d0c0057e1312024-03-14WarningsExact identifier
unii: 45P3261C7T
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCfdee1637-8049-4bc5-b196-b6d854c9f9f32024-03-05WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Grain and Soy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, QUERCETIN, RUTIN, NATRUM CARBONICUM, ILEUM (SUIS), JEJUNUM (SUIS) STOMACH (SUIS), GLUTEN, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, CORTISONE ACETICUM, GLYPHOSATE, SYCOTIC CO BACILLUSDeseret Biologicals, Inc.c34957b3-d2e8-4d28-b0eb-0e96cb7b83a62024-02-22WarningsExact identifier
unii: 45P3261C7T
NicotineNICOTINE POLACRILEXWalgreens446c857f-2380-4019-9a82-9fb9ee060d082024-02-21WarningsExact identifier
unii: 6M3C89ZY6R
up and up nicotineNICOTINE POLACRILEXTarget Corporation65a612e8-18d3-49fd-844f-4ccd0210acd32024-02-20WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
up and up nicotineNICOTINE POLACRILEXTarget Corporationc0c667b8-7384-4970-8f27-f108192c32562024-02-20WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreens19bd0eb4-0cd6-4979-bef6-eedbd4d5de882024-02-20WarningsExact identifier
unii: 6M3C89ZY6R
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.105975ec-82ea-dbfb-e063-6394a90a4fd12024-02-01WarningsExact 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, LAC FELINUM, NAJA TRIPUDIANS, RHUS GLABRA, ROSA DAMASCENA, SABADILLA, AURUM METALLICUM, MAGNESIUM IODIDE, CARCINOSINDeseret Biologicals, Inc.b5e02000-1861-4477-a203-471ef845b1d22024-01-31WarningsExact identifier
unii: 45P3261C7T
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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