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 26 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Nicotine Sugar FreeNICOTINE POLACRILEXCVS Pharmacy63fce25d-457f-4048-86a4-1805f603936c2025-08-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporation9f77adad-4b67-48c8-9ad4-24bccdea3ae22025-08-26WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC47561b44-572e-4ca0-b91c-db07061313632025-08-25WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Maxi NicotineNICOTINE POLACRILEXRite Aid Corporation1472b0a3-5ff1-44e7-8748-a3b1a5e551962025-08-25WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Indigestion-GasCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c1c1525-9752-275d-e053-2a95a90acf432025-08-20WarningsExact identifier
unii: 45P3261C7T
Indigestion-GasCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9c1cd511-64d4-3607-e053-2995a90a60292025-08-20WarningsExact identifier
unii: 45P3261C7T
Nicotine MiniNICOTINE POLACRILEXRite Aid Corporation876b80a3-3ea8-4821-9716-c18e245028222025-08-20WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXH E Bf3e395db-61e8-43cb-bf95-8cacd17f5d9a2025-08-13WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Company6c5d786b-8b5a-460a-ae67-c11de9858ad42025-08-10WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Companyaf8fadbb-25a7-4ab7-a665-808e4b41978a2025-08-08WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXRite Aid Corporation63a433aa-8c73-47a0-be64-8708f8478fff2025-08-07WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINUMNICOTINEBoiron3b8cb10e-6fbb-c542-e063-6294a90a967a2025-08-04Exact identifier
unii: 6M3C89ZY6R
Nicorette PeppermintNICOTINE POLACRILEXHaleon US Holdings LLC990a4a65-d573-46a9-889d-60afb00189442025-07-31WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems Inc.7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe2025-07-30WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEStrategic Sourcing Services LLCa08022ff-e412-47f9-8132-318f55528c5c2025-07-30WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepackc2627853-945b-42d8-8351-39028e513d772025-07-29WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack16ece78d-c66e-43c1-953a-f774797ae0972025-07-29WarningsExact identifier
application number: ANDA203690
ndc (package): 71335-2730-1
ndc (product): 71335-2730
rxcui: 359818
spl id: 5189572b-3c8e-403b-b2bc-132963a86981
spl set id: 16ece78d-c66e-43c1-953a-f774797ae097
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.a18dde9f-700f-4572-a6aa-577dbacdf3142025-07-29WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXLucy Goods, Inc.20aa42c6-14e3-46c5-ba0f-fef217e0b1c22025-07-29WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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