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 27 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXLucy Goods, Inc.bca1c2ab-2263-429d-9f09-f848dd3d826e2025-07-21WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.150faf42-491f-403b-869b-48edd431d1cc2025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Maxi NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.7c2e0872-75f6-4c4f-afff-3579375708de2025-07-18WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXRugby Laboratories, Inc.be17cbe9-43bb-424e-9d91-fba4f02691bb2025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.76034dd1-361c-442c-92aa-8fa7cf47a5072025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
unii: 6M3C89ZY6R
good sense nicotineNICOTINE POLACRILEXA-S Medication Solutions3e9a5f94-9db2-4cac-8ab9-50fcedfe0e052025-07-16WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
stop smoking aidNICOTINE POLACRILEXPublix Super Markets Inc5f205c02-e3a1-4fa1-8cb6-b4da52662c002025-07-14WarningsExact identifier
unii: 6M3C89ZY6R
KLOR-Con/EFPOTASSIUM BICARBONATEUpsher-Smith Laboratories, Inc.f9d85c4f-aa46-40b2-ad76-89dbf6ec8e4d2025-07-14Warnings, Adverse reactionsExact identifier
unii: HM5Z15LEBN
NICODERM CQNICOTINEHaleon US Holdings LLC93b2d1b9-83c1-40b5-b6af-90c38c8d6cef2025-07-14WarningsExact identifier
unii: 6M3C89ZY6R
Quality Choice Fiber CapletsCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)29dbc831-23c1-487d-902a-9404d9ebe8052025-07-09WarningsExact identifier
unii: 8F049NKY49
Mini NicotineNICOTINE POLACRILEXChain Drug Consortium, LLC380ce6c2-3e29-4bdf-a600-f6990925a3072025-06-30WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine Polacrilex, OriginalNICOTINE POLACRILEXChain Drug Consortium, LLCcb67cd5e-9264-4530-a678-da299476f3562025-06-30WarningsExact identifier
unii: 6M3C89ZY6R
Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.38c1616e-3b09-0669-e063-6294a90a2c862025-06-29WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.31e0dadd-2678-4e3c-9e62-e3766c21ce5f2025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.a0fc3eae-9c34-48af-bdd2-d95e91b68a9c2025-06-27WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Rugby Nicotine Polacrilex Gum, Original FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.57e08517-4c8a-487a-bfbe-2a43f105f4b92025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXATLANTIC BIOLOGICALS CORP.62609a8d-bcbe-420c-aed8-edfdf022ff262025-06-27WarningsExact identifier
unii: 6M3C89ZY6R
Aroamas Cot Nicotine Transdermal Patches KitNICOTINE TRANSDERMAL PATCHESPCHEERY LLC38576022-9413-c9af-e063-6294a90afd462025-06-24WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine transdermal systemNICOTINESam's West Inccd9aa56c-ac88-4f9b-9ff9-a9720af6c1a72025-06-10WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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