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 24 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc27c579b5-1021-4551-9680-bf8978e1d9b42025-11-18WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems, Inc.55442645-fa9b-4a9b-81e2-345ad062a1242025-11-18WarningsExact identifier
unii: 6M3C89ZY6R
STPSMK QUIT SMOKING NICOTINE PATCHESNICOTINEGuangzhou Ouruisi Biotechnology Co., Ltd43c1b4e9-39ee-d398-e063-6394a90a71f02025-11-16WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC17b00f7a-50ac-46ac-b172-6c6c35e9ca7b2025-11-15WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
members mark NicotineNICOTINE POLACRILEXSam's West Incc31c30b9-7431-4b90-b011-f34e499df1922025-11-15WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
nicotineNICOTINE POLACRILEXWalgreen Companyb1154b04-b3a6-4af9-a933-486c5501d46e2025-11-11WarningsExact identifier
unii: 6M3C89ZY6R
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Calcium PolycarbophilCALCIUM POLYCARBOPHILLEADER/ Cardinal Health 110, Inc.b4637e18-c65f-0e81-e053-2a95a90a22842025-11-06WarningsExact identifier
unii: 8F049NKY49
up and up fiber therapyCALCIUM POLYCARBOPHILTarget Corporation.e5473950-06f4-4ea4-975b-3ac94957e7762025-11-04WarningsExact identifier
unii: 8F049NKY49
MedlineNICOTINEMedline Industries, LPe11a4b7e-6f1f-24db-e053-2a95a90a0d092025-11-04WarningsExact identifier
unii: 6M3C89ZY6R
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Fiber CapletsCALCIUM POLYCARBOPHILSAFEWAY08e2e8b0-90b3-48d6-a72a-40688c74771a2025-10-29WarningsExact identifier
unii: 8F049NKY49
PUBLIXCALCIUM POLYCARBOPHILPUBLIX SUPER MARKETS, INC02e3f4ce-8961-425c-98a9-3b9d66709ca52025-10-28WarningsExact identifier
unii: 8F049NKY49
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NicotineNICOTINE POLACRILEXCVS Pharmacy794606a1-12e7-405e-81b2-33ce3fd618322025-10-21WarningsExact identifier
unii: 6M3C89ZY6R
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
unii: 8F049NKY49
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
unii: 6M3C89ZY6R
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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