FDA.reportPublic FDA data

NDC 45802-089-01 - 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
45802-089
Requested NDC
45802-089-01
Package NDCs from labels
45802-089-01, 45802-089-02
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2026-04-30
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 Ltd2026-04-30HUMAN 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
45802-089-01Nicotine Polacrilex27 in 1 CONTAINERLOZENGE274
45802-089-02Nicotine Polacrilex3 in 1 CARTONLOZENGE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-089NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 2 package rows20250228_b765570e-e5b5-48e4-b4d2-2a85ac19a2ea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-089-01EA - Each45802-0892761a663-9f19-4540-8d44-12ddfad2eee412026-05-22

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 29 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCc7f32ab1-f6bd-46f5-9852-8eb5b78a33262025-04-25WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCffeb8286-860d-49f5-8df3-724afb4aaad82025-04-25WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine transdermal system step 3NICOTINEGolden State Medical Supply, Inc.7c83d507-7e8d-496c-bb9d-63abfa25c7a72025-04-17WarningsExact identifier
unii: 6M3C89ZY6R
Fiber LaxativeCALCIUM POLYCARBOPHILGeri-Care Pharmaceutical Corp616b4399-7626-5e59-e053-2a91aa0a0f752025-04-07WarningsExact identifier
unii: 8F049NKY49
Nicotine PolacrilexNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4af800f9-bcb3-4320-8d32-f1bfd54ee5e92025-04-03WarningsExact identifier
unii: 6M3C89ZY6R
Calcium PolycarbophilCALCIUM POLYCARBOPHILCITRAGEN PHARMACEUTICALS, INC.b23dd90f-ba5a-80fc-e053-2995a90a22862025-04-03WarningsExact identifier
unii: 8F049NKY49
nicotineNICOTINE POLACRILEXMeijer, Inc.8b9f4dfc-9469-449d-9434-656aeccc4fd62025-04-03WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack094de23b-d433-487d-8364-6f245c8117c62025-04-03WarningsExact identifier
application number: ANDA203690
ndc (package): 72162-2287-2
ndc (product): 72162-2287
rxcui: 359817
spl id: 9e137a96-1789-4a85-8578-a618ded2a32a
spl set id: 094de23b-d433-487d-8364-6f245c8117c6
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack3997dda6-89ea-49df-abda-ab420327a4732025-04-03WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXPLD Acquisitions LLC DBA Avma Pharma Solutions71db232e-b169-47d0-b269-5e14fa75f3a22025-03-27WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
SEFUDUN QUIT SMOKING NICOTINE PATCHESNICOTINEShenzhen Shandian Jingling Technology Co., Ltd.314e6f25-8fd0-38ba-e063-6294a90aca8b2025-03-27WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMWalgreens5aadb95f-428c-b637-01f4-50d5866ced0c2025-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMBluePoint Laboratoriesa8a769ce-e41a-696f-e053-2a95a90a6b182025-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD313b08e2-d764-96da-e063-6294a90ab7052025-03-25WarningsExact identifier
unii: 6M3C89ZY6R
HypothaltemEUPATORIUM PERFOLIATUM, BERBERIS VULGARIS, MENTHA PULEGIUM, MOSCHUS, BENZINUM, SEPIA, BARYTA CARBONICA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, THYROIDINUM (SUIS), PYRIDOXINUM HYDROCHLORICUM, GELSEMIUM SEMPERVIRENS, NATRUM CARBONICUM, NUX VOMICA, STAPHYSAGRIANucleic Products, LLCb95050f2-f40d-4e84-8752-4d7ad75390c92025-03-20WarningsExact identifier
unii: 45P3261C7T
nicotineNICOTINE POLACRILEXWalgreen Company4a81d378-009d-43a9-a895-e371ffa700e92025-03-19WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.2f829466-f2fb-43f1-9e82-0d33b50b913a2025-03-17WarningsExact identifier
unii: 6M3C89ZY6R
Bestmade Natural Products Restful Legs SupportCALCAREA PHOSPHORICA, ACONITE NAP, ANACARDIUM ORI, ARGENTUM NIT, ARSENIC ALB, AURUM MUR, CHAMOMILLA, DUBOISIA, GELSEMIUM, IGNATIA, KALI BROM, LACHESIS MUTUS, LYCOPODIUM, MAG MUR, MOSCHUS, NAT CARB, NAT SULPH, PHOSPHORIC ACID, RAUWOLFIA SERPBestmade Natural Products304b48ac-c4b8-a5c0-e063-6394a90a07b62025-03-14WarningsExact identifier
unii: 45P3261C7T
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 96K6UQ3ZD4

Reported adverse events (FAERS/openFDA)#

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