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 34 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.0fb69003-c66c-97ad-e063-6394a90a4c9b2024-01-24WarningsExact identifier
unii: 45P3261C7T
Good Sense NicotineNICOTINE POLACRILEXA-S Medication Solutionsd84f27e4-c63b-4d04-9e65-bdb1a3594f922024-01-22WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette 4mg Fruit Chill Gum, Lil Drug StoreNICOTINE POLACRILEXLil' Drug Store Products, Inc.0e85dcfa-d9e1-5fbb-e063-6394a90aeae62024-01-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette 4mg White Ice Mint Gum, Lil Drug StoreNICOTINE POLACRILEXLil' Drug Store Products, Inc.0e894f4f-2d41-24c2-e063-6294a90ae26c2024-01-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicorette 4mg Cinnamon SurgeNICOTINE POLACRILEXLil' Drug Store products, Inc.0e74e9fd-f79a-ffea-e063-6394a90a721e2024-01-08WarningsExact identifier
unii: 6M3C89ZY6R
A03 ULTRA ANTITOXALFALFA, AMERICAN GINSENG, APIS MELLIFICA, ASPARAGUS OFFICINALIS, AVENA SATIVA, BARYTA IODATA, BERBERIS VULGARIS, BRYONIA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, CONIUM MACULATUM, FERRUM IODATUM, LAPIS ALBUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, PASSIFLORA INCARNATA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, UVA URSIApex Energetics Inc.b945cb81-aee4-38e8-e053-2a95a90aa8df2024-01-08WarningsExact identifier
unii: 45P3261C7T
good sense nicotineNICOTINE POLACRILEXA-S Medication Solutions24cffa97-44fb-4b29-a876-b9c040b607482024-01-04WarningsExact identifier
unii: 6M3C89ZY6R
FIBER LAXATIVECALCIUM POLYCARBOPHILMagno-Humphries, Inc.e4a921c5-1cf7-12ca-e053-2a95a90a6e042024-01-03WarningsExact identifier
unii: 8F049NKY49
Nicotine Sugar FreeNICOTINE POLACRILEXCVS Pharmacy8986c712-6399-450e-8178-01fef29ebc522023-12-22WarningsExact identifier
unii: 6M3C89ZY6R
up and up cherry nicotineNICOTINE POLACRILEXTarget Corporation4e0d57ea-749f-48ff-b6f1-3cbd0963d11e2023-12-12WarningsExact identifier
unii: 6M3C89ZY6R
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 Biologicals6051c9d5-36ef-4bfa-baab-9862c94805fb2023-12-12WarningsExact identifier
unii: 45P3261C7T
Nicotine PolacrilexNICOTINE POLACRILEXA-S Medication Solutionsbee5365b-e7f1-493a-baec-8604bd5550e32023-12-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXA-S Medication Solutions6c814edf-0917-4e48-8d26-931b1db278802023-12-09WarningsExact identifier
unii: 6M3C89ZY6R
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron8644adda-42ae-b595-e053-2991aa0ac78b2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron864460f9-db50-3e37-e053-2a91aa0ab03f2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron864414b8-957a-7580-e053-2a91aa0a231d2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron86448954-413c-b8af-e053-2991aa0a68ad2023-11-14Exact identifier
unii: 45P3261C7T
NicotinumNICOTINEBoiron7f6f83a5-f680-6ce2-e053-2991aa0ab8fc2023-11-14Exact identifier
unii: 6M3C89ZY6R
Natrum carbonicumSODIUM CARBONATEBoiron86441779-8449-5d05-e053-2991aa0a10c22023-11-14Exact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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