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 37 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier
unii: 6M3C89ZY6R
Natrum carbonicumSODIUM CARBONATEBoiron864414b8-9568-7580-e053-2a91aa0a231d2023-01-05Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron8644c5d1-4db3-fac8-e053-2a91aa0a8d6d2023-01-05Exact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0315c9e-8922-c0b5-e053-2a95a90ae54e2022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f031e256-fca5-3939-e053-2995a90a4fe62022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0328097-e5d2-3532-e053-2a95a90a93f02022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f032e7bb-a6fd-2951-e053-2a95a90a8c3a2022-12-19WarningsExact identifier
unii: 45P3261C7T
MUNDIPURBRYONIA DIOICA ROOT, COLCHICUM AUTUMNALE BULB, SODIUM CARBONATE, PHYTOLACCA AMERICANA ROOT, BERBERIS VULGARIS ROOT BARK, CYNARA SCOLYMUS WHOLE, HARPAGOPHYTUM PROCUMBENS ROOT, AND LEDUM PALUSTRE TWIGPEKANA Naturheilmittel GmbH4aeba0c8-0d53-4012-8024-df1e82585cb32022-12-16WarningsExact identifier
unii: 45P3261C7T
Nicotine MiniNICOTINE POLACRILEXEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)4eeaf22c-a839-49c5-b099-77321d590d062022-12-06WarningsExact identifier
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc8c66eb21-dd95-4dcb-8488-e1e768dd8cd62022-12-06WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy4853ee32-521f-4359-8084-438893be43bc2022-11-22WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCVS Pharmacy7fa848c6-3a4a-41f3-b927-1b26b6232e3a2022-11-22WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy8332bb07-72a7-491e-a19b-baff84acefdb2022-11-22WarningsExact identifier
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafewaycb2624de-3908-4091-aea1-f0dc76abd6332022-11-15WarningsExact identifier
unii: 6M3C89ZY6R
Natrum CarbonicumNATRUM CARBONICUMHahnemann Laboratories, INC.ecee3632-9ca1-6e93-e053-2a95a90afb582022-11-07Exact identifier
unii: 45P3261C7T
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC85f05cc6-ae2e-4338-8c1e-c681c2f908582022-11-03WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIAurohealth LLCcfe6fb63-2897-4e76-8288-1389f363b3c42022-11-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 7000071ee5a44-b451-4ecd-9fe7-8124b4dae1c52022-10-20WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 700006edf8c50-d3b9-469a-ad57-37c05e0988622022-10-20WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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