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 35 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum carbonicumSODIUM CARBONATEBoiron87fddb6a-d890-78a5-e053-2a95a90ac2aa2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron81bf8b10-7c5f-11e6-8655-424c583030312023-11-14Exact identifier
unii: 45P3261C7T
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.99eb7b5d-926d-aa16-e053-2a95a90a08342023-11-07WarningsExact identifier
unii: 45P3261C7T
GOOD SENSENICOTINE POLACRILEXA-S Medication Solutionsdece0a8d-a7df-446f-bfcf-9f96e8bfc4ae2023-10-31WarningsExact identifier
unii: 6M3C89ZY6R
Fiber LaxativeCALCIUM POLYCARBOPHILMagno-Humphries, Inc.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
unii: 8F049NKY49
CareOne Mini Nicotine PolacrilexNICOTINE POLACRILEXAmerican Sales Companyd3591f0c-f638-485a-ab34-f71fce6a966f2023-10-25WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC7eed43bd-b26c-41cd-b2bc-74d6c15b376c2023-10-25WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4856d5df-3b77-465e-b6a9-38d00854f9672023-10-23WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
care one nicotineNICOTINE POLACRILEXAmerican Sales Company1b6be939-cd9d-4ab4-b291-096cf498cf922023-10-20WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
careone nicotineNICOTINE POLACRILEXAmerican Sales Company84ed0acf-dcd3-4d4a-8e5c-f75f48993b342023-10-20WarningsExact identifier
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC4547ec2b-1543-4ce3-bdde-c0b292cdfcc12023-10-16WarningsExact identifier
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC60420337-ce44-403e-943f-2a7964e733062023-10-16WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC5fa9ffff-1511-474b-8342-f366b397de092023-10-13WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: TTV12P4NEE
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: TTV12P4NEE
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: TTV12P4NEE
euqate nicotineNICOTINE POLACRILEXWALMART INC.c1764aad-1da4-4e4e-b6b0-5a3df1edda852023-08-31WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCVS Pharmacye23ad78b-f151-44bb-8dfd-7e933c0d11522023-08-30WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCa0ceda92-78e7-417f-adfc-a085f9b185842023-08-28WarningsExact identifier
unii: 6M3C89ZY6R
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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