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 38 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReBoostSILVER NITRATE,EUPHORBIA RESINIFERA RESIN, CALCIUM SULFIDE, GOLDENSEAL, POTASSIUM DICHROMATE,LUFFA OPERCULATA FRUIT, SODIUM CARBONATE, ECHINACEA UNSPECIFIED, CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE AND PULSATILLA VULGARISMediNaturacb8a8d2a-d9d2-4a71-9279-c5641a9126c62022-07-19WarningsExact identifier
unii: 45P3261C7T
NICOTINENICOTINE POLACRILEXAurohealth LLC810932e0-a982-400a-b43d-b847152f685b2022-06-24WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCdcc0b057-3d5e-4aeb-ac31-478d7a2f47fa2022-06-24WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLC1909cf25-bce8-4880-abc6-548d28a7285d2022-03-07WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCfa730ae3-c2b3-4ea4-8e50-f819b205d1682022-03-07WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCafc71ce1-ded2-4259-a9e1-faca692b90a12022-01-11WarningsExact identifier
unii: 6M3C89ZY6R
Headek NasalBELLADONNA, GLONOINUM, COFFEA, NATRUM CARB, NATRUM MUR.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics976b9c85-68c9-46a5-9012-53cb24683b032021-12-29WarningsExact identifier
unii: 45P3261C7T
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: 45P3261C7T
Rexall NicotineNICOTINE POLACRILEXDolgencorp, LLC83b053f6-304b-4f9c-8a6d-6649998708b22021-12-15WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC6f73126a-32e5-48b9-8013-6afb0ebe8fd82021-09-28WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC8cc8de15-5906-4749-99f2-2884c6a1842a2021-09-07WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Service0294974c-8d07-4a2e-b929-648c712b6ebe2021-06-01WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Servicec1f1048b-e581-45bf-b344-8e2b0b7488bb2021-05-27WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyfac52e0d-7a02-451e-a36b-30d49e929d3e2021-03-31WarningsExact identifier
unii: 6M3C89ZY6R
Candid- YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68c9c20-3a07-16df-e053-2a95a90a0cbc2021-02-01WarningsExact identifier
unii: 45P3261C7T
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c68ea9c3-f95c-dbcd-e053-2995a90a9aeb2021-02-01WarningsExact identifier
unii: 45P3261C7T
Candid-YADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.Newton Laboratories, Inc.c6a37dbe-3092-5ecf-e053-2a95a90a7c392021-02-01WarningsExact identifier
unii: 45P3261C7T
AllergyALLIUM SAT, ANACARDIUM, APIS MEL, GAMBOGIA, MERC SOLUB, NAT CARB, NITRICUM AC, NUX VOM, PHOSPHORUS, PULSATILLA, SULPHURNet Remedies0b7129bf-c0de-496c-81f5-286d5ce8d82c2021-01-21WarningsExact identifier
unii: 45P3261C7T
Day and Night VitalsALLIUM SAT, ALOE, ARSENICUM ALB, BERBER VULG, CALC PHOS, CEANOTHUS, CHELIDONIUM MAJ, CHOLESTERINUM, CLEMATIS ERECTA, CONDURANGO, GAMBOGIA, HAMAMELIS, KALI BROM, KALI PHOS, LYCOPODIUM, NAT CARB, PASSIFLORA, SENNA, SILICEA, SOLIDAGO, SPIGELIA ANTH, SPONGIA, VERATRUM VIRNET Remediesd5ddba51-5f0c-4b06-8f87-3cd6faf64b792021-01-19WarningsExact identifier
unii: 45P3261C7T
EarthAUR MET, ARG NIT, CAUSTICUM, CINCHONA, CONDURANGO, CEANOTHUS, EUPHRASIA, FUCUS, GALLICUM AC, IRIS VERS, NET CARB, NITRICUM AC, PHOSPHORUS.NET Remedies06bfa185-71a2-4297-9a02-a9951a004bc52021-01-19WarningsExact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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