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 23 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.a3f19365-d0d1-43ad-be15-48dc4320e3612025-12-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.e86b9c22-7ee0-4bd0-adfd-a7b087b1dd712025-12-06WarningsExact identifier
unii: 6M3C89ZY6R
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC5d23992f-a010-4604-b64c-94ab6b134e6d2025-12-04WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: HM5Z15LEBN
Quitine nicotineNICOTINE POLACRILEXQUITINE LLC90232b4e-cbf4-4d03-973a-41f4ebb4e5de2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
quitine mini nicotineNICOTINE POLACRILEXQUITINE LLC0781ddbd-45c4-4191-898a-50c71644965c2025-12-04WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
QUITINE MINI NICOTINENICOTINE POLACRILEXQUITINE LLCd856379c-6334-4069-8382-ded2f86cf8a42025-12-04WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Equalactin LaxativeCALCIUM POLYCARBOPHILNUMARK BRANDS, INC2feed33a-3b7f-11c6-6e62-c99150ecfddd2025-12-03WarningsExact identifier
unii: 8F049NKY49
Quality ChoiceCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f1e69c65-c1b0-459f-9a12-b1a92b90036b2025-12-03WarningsExact identifier
unii: 8F049NKY49
NWRB Nicotine Transdermal PatchNICOTINEDongkou County Hecheng Network Technology Co., Ltd.44f3e697-1859-dab0-e063-6294a90a45172025-12-02WarningsExact identifier
unii: 6M3C89ZY6R
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
unii: 8F049NKY49
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
unii: 8F049NKY49
Walgreen Fiber LaxCALCIUM POLYCARBOPHILWALGREENS CO.9cbe1798-e0dc-4a90-bd91-8696fc59b2a62025-11-25WarningsExact identifier
unii: 8F049NKY49
NicDuic Quit Smoking Nicotine Patches 3 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4429fea8-46f8-8f7f-e063-6394a90a34b42025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
NicDuic Quit Smoking Nicotine Patches 2 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442a926b-d7c1-4e35-e063-6394a90ad9482025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
NicDuic Quit Smoking Nicotine Patches 1 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442aae32-4ac6-5dd6-e063-6294a90aad022025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
NicDuic Quit Smoking Nicotine Patches 1-3 Step21MG NICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442ae0fa-a1ed-7901-e063-6294a90ab7172025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWALMART INC.a4540259-78c1-4da2-a465-8a4cfe29a2902025-11-19WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWALMART INC.86c2cac9-4b7b-4b80-9ca1-32634304449e2025-11-19WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company477689fc-688a-4c76-8c02-35a7a15adc5e2025-11-19WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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