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 5 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inca9402b4b-f8e6-4e96-ad45-5875dfd0c8892026-07-10WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inca0113a1d-3691-4f18-9950-ae6d8d7d19ea2026-07-10WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Lozenge MintNICOTINE POLACRILEX LOZENGE 2 MGDr. Reddy's Laboratories Inc.836bae74-076b-3c92-dee9-22b8519b529d2026-07-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.003b863c-06b0-715d-ccc2-b7da4deac6212026-07-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Habitrol Lozenge Original FlavorNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.87714b79-05b3-f3c2-6505-5923e4f488712026-07-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Habitrol Lozenge CherryNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5a464242-7d63-141e-808e-c41676cf4b782026-07-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inc8cb5577b-48c0-47f8-8979-0ab54d7130452026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6b0342dd-120f-a16e-098a-dc45b14d3d3a2026-07-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
DG HEALTH NICOTINENICOTINE POLACRILEXDolgencorp Incb44f0525-abf6-461d-ae15-40d162021eaa2026-07-01WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine Transdermal System step 3NICOTINEAmerisourceBergen Drug Corporatione51d2c09-a20f-eb9b-e3e4-013f3e488ab32026-07-01WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC03d9708a-923c-4fd3-ac3d-6ab4a4d8a8042026-06-30WarningsExact identifier
unii: 6M3C89ZY6R
topcare nicotineNICOTINE POLACRILEXTopco Associates LLCc3c52b83-fdbe-4999-b982-37c63462eb7c2026-06-30WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCf0f79275-c27a-4d35-a79a-53b0905c37612026-06-29WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc768e3f3d-d867-4574-8a5d-07572e2e4a042026-06-29WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B9bf10dfc-c6df-4cc9-ba79-2dcf874a29042026-06-26WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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