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 22 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Habitrol Nicotine Polacrilex 2 mg Coated CinnamonNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6874a9f1-d180-4073-8226-df6e21bcf0b72025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Gum 4 mg Coated FruitNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5d3b45d6-97c2-4400-ad09-95a4b21f53242025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex 4 mg Coated CinnamonNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5c394758-1179-455a-a562-c8e954fb22582025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON FIBER CAPLETSCALCIUM POLYCARBOPHILAMAZON.COM SERVICES LLC178f4150-c75c-45e1-a5f3-3af67b5c81092025-12-22WarningsExact identifier
unii: 8F049NKY49
Habitrol Nicotine Polacrilex Gum 2 mg Coated MintNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.826f0ce5-9862-4f6f-8943-a3f06b07e69f2025-12-22WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Gum 2 mg Coated FruitNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.dc811e89-e104-4fdf-aabf-f73d41d85f4c2025-12-22WarningsExact identifier
unii: 6M3C89ZY6R
L-TransLYMPH SYSTEM BOOSTERVitality Works, Inc.72ccb9be-2d62-414a-856a-7fcea51f26d22025-12-17WarningsExact identifier
unii: 6M3C89ZY6R
Irritable Bowel Syndrome TherapyASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT -TRP Company04149220-c7ce-4312-9630-f93d6def3aaa2025-12-15WarningsExact identifier
unii: 45P3261C7T
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.45a7e1cf-7182-6ec3-e063-6394a90ae4412025-12-11WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXKroger Company69a61101-df32-444e-a49a-eccfeebfb20e2025-12-11WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
GUHIO Nicotine PatchNICOTINEGuangxi Keyun E-commerce Co., Ltd.45a53cd6-3e3f-697a-e063-6394a90a6c832025-12-10WarningsExact identifier
unii: 6M3C89ZY6R
mini nicotineNICOTINE POLACRILEXMeijer Distribution Inca5528828-cd03-46fc-a13c-3ccae1c0dc5c2025-12-10WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC41ae65b3-2e4e-4306-959d-be44c7d205fe2025-12-10WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
unii: 6M3C89ZY6R
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2NICOTINE TRANSDERMAL PATCHESPCHEERY LLC4580d7f0-92a9-d0d0-e063-6394a90ac3932025-12-09WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCf3035ca0-8739-4d77-af97-f6021d6478c22025-12-09WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC6b500780-f45c-477c-8371-3b60e33050002025-12-08WarningsExact identifier
unii: 6M3C89ZY6R
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXMeijer, Inc.084f9d77-b4ab-4328-8ff4-cdc7523daebe2025-12-08WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXRising Pharma Holdings, Inc.05990040-5bd7-4622-8fe3-2d7573904dfa2025-12-06WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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