FDA.reportPublic FDA data

NDC 45802-873-03 - 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
45802-873
Requested NDC
45802-873-03
Package NDCs from labels
45802-873-03, 45802-873-05
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2026-01-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex Lozenge 4 mg Drug FactsNuCare Pharmaceuticals, Inc.2026-01-27HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2025-10-07HUMAN OTC DRUG LABEL
Nicotine Polacrilex - A-S Medication SolutionsA-S Medication Solutions2023-12-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-873-03Nicotine Polacrilex24 in 1 CONTAINERLOZENGE246
45802-873-05Nicotine Polacrilex3 in 1 CARTONLOZENGE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-873NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 2 package rows20250116_8d4dfba9-1571-4128-9cdc-47cdce04e3e4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-873-03EA - Each45802-873753e6cf1-f5ce-420f-9076-d2beac103eef12025-10-14
45802-873-05EA - Each45802-873cfb4c721-af2d-4d5f-8a74-a2fb15a2e5c612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1NICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICOTINE POLACRILEX LOZENGE [PERRIGO NEW YORK INC]1

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 9 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdf9759891-7d3d-4714-8f8b-92d0a499e52e2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc2c43a498-a4fb-4ed1-b4ae-aecfd334945b2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
blipNICOTINE POLACRILEXBlip Products, Inc.451863c3-4c17-448e-9225-a5492344af152026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc8828d4f5-7b3a-4f1c-8f78-fa820ffa84412026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc8edad777-6491-4ab2-9835-709bf54d5f0c2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc0ea1d300-d77a-4262-b74c-583455606a2c2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
Members Mark NicotineNICOTINE POLACRILEXSam's West Incbb8ec4c2-7f1a-4069-9677-8bf645d18e322026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.ad5fc90e-d3b4-4701-bfd8-1cda9087d09a2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
dg health nicotineNICOTINE POLACRILEXDolgencorp Inc64b2982d-491e-42e7-b65e-7abf5530b9352026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltd26edb714-656d-49ca-b875-28972c490e5f2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
GUNA-BOWELALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -Guna spa75465821-a889-4697-b470-e9588a5232052026-06-10WarningsExact identifier
unii: 45P3261C7T
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLCa7e3da43-693b-44df-8566-4847edae9d612026-06-10WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXMeijer Distribution Incdc6b806a-f571-4d33-9b93-3dcd21ad02602026-06-09WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC63ac801f-02ed-43a1-a2a8-2ad35d8fd7a92026-06-09WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC90f2da70-c58f-44fb-bdbd-5c95440c11982026-06-08WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporation8b24aefd-1881-4126-9188-29896a17a06d2026-06-03WarningsExact identifier
application number: ANDA077007
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.4d724a5a-425e-e441-e063-6294a90a761e2026-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.4d70b8f1-31ab-4aa1-e063-6294a90a13a92026-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.4d7219e6-17a9-b7d9-e063-6394a90a465e2026-06-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXHyVee Inc7e391e5d-a715-42ae-8c4d-0a7d1a8599892026-06-03WarningsExact identifier
application number: ANDA077007
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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