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 36 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINENICOTINE POLACRILEX MINIBLIP PRODUCTS, INC.e88c8815-4d38-3a59-e053-2995a90afc822023-08-11WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIBLIP PRODUCTS, INC.eb714022-332d-5c6f-e053-2a95a90a75c92023-08-11WarningsExact identifier
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc0100787d-59f0-4f7f-ac13-92d1162cdc1b2023-08-04WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Incd0e94dfb-017a-4faf-8423-3417d517f39c2023-08-03WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCd6566f92-cf41-4032-a66b-3d1cdf661f332023-08-01WarningsExact identifier
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc265e7411-45cd-4bd2-98fc-0401dfa524342023-07-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc43a24aa7-ba1c-4c5d-9ec8-ed496e299e002023-07-28WarningsExact identifier
unii: 6M3C89ZY6R
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: 45P3261C7T
equate nicotineNICOTINE POLACRILEXWALMART INC.0f625e1a-be08-4460-a588-8b42282ac1212023-06-15WarningsExact identifier
unii: 6M3C89ZY6R
topcare nicotineNICOTINE POLACRILEXTopco Associates LLC872d8ba6-881c-49f2-9848-1ed3eed768602023-06-15WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Companyd2572335-9c54-4745-9a11-eb9b8d34d0cd2023-06-14WarningsExact identifier
unii: 6M3C89ZY6R
AllerforceCHONDRUS CRISPUS, GLYCYRRHIZA GLABRA, SARSAPARILLA, ZINGIBER OFFICINALE, ADRENALINUM, ALLIUM CEPA, ARALIA RACEMOSA, ARSENICUM ALBUM, CALCAREA CARBONICA, CANTHARIS, IODIUM, NATRUM CARBONICUM, RHUS TOX,BioActive Nutritional, Inc.667036a4-2a89-45c3-a7cc-4b37d735fa4a2023-06-05WarningsExact identifier
unii: 45P3261C7T
Kirkland Signature NicotineNICOTINECostco Wholesale Company0888a974-a8ba-4cb3-996f-c8abfcb90a6f2023-06-01WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Company8af06c23-80b7-4559-b594-a3a02297306d2023-05-28WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
Kirkland Signature NicotineNICOTINECostco Wholesale Company33098a72-9146-4547-9d0b-ff28c8c800302023-05-26WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
kirkland signature quit 2NICOTINE POLACRILEXCostco Wholesale Companycb462e10-124e-4ea3-9261-8c1fc7a9e1a62023-05-18WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companycd1c3493-242c-4981-8561-ebbea938628f2023-05-12WarningsExact identifier
unii: 6M3C89ZY6R
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: C269C4G2ZQ
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab184645-6fff-40cf-9859-4b8dec9098b22023-03-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab1df1b4-a831-4de2-be87-38b9cd589db92023-03-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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