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 4 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
unii: 6M3C89ZY6R
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc00b40bb3-3785-4a53-804e-633795e87f712026-07-20WarningsExact identifier
application number: ANDA077007
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc31b1a48e-8651-41d7-b693-6509a344906a2026-07-20WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories621eb214-0716-4306-829f-6185a77f24d52026-07-16WarningsExact identifier
unii: 6M3C89ZY6R
nicotine miniNICOTINE POLACRILEXAmazon.com Services LLCcc6fd7f3-8ba2-4d60-bafa-a6716f65545e2026-07-16WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc2eca67db-1b7c-43dd-91af-4060e9b8e9d32026-07-15WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories1fc88637-4329-486e-82ab-19eeb06080a62026-07-15WarningsExact identifier
unii: 6M3C89ZY6R
EQUATE NICOTINENICOTINE POLACRILEXWALMART INC.b6379f86-1528-465d-9527-bd2fead0068f2026-07-15WarningsExact identifier
application number: ANDA077007
unii: 6M3C89ZY6R
kirkland signature quit 2NICOTINE POLACRILEXCostco Wholesale Companyccee1b99-e58b-4377-9ae8-9f215e2c975d2026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratoriesd67149d5-4766-4b84-8205-f1a6b692f4c92026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companybfdf3918-3116-4351-b0a8-4c515e2e1f412026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
Kirkland Signature Quit 2NICOTINE POLACRILEXCostco Wholesale Company17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c12026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companyb9dd4e89-0023-4552-bdd6-1c046ce3bd872026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
coated nicotineNICOTINE POLACRILEXPublix Super Markets Inc97b06ada-b8b8-49fc-bc65-c3e835ef149b2026-07-13WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company5c89061b-1452-4962-9f25-212f2ae8e41e2026-07-13WarningsExact identifier
application number: ANDA077007
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc61c69497-91f9-45bf-ad48-33ac73e63a752026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inca9402b4b-f8e6-4e96-ad45-5875dfd0c8892026-07-10WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inca0113a1d-3691-4f18-9950-ae6d8d7d19ea2026-07-10WarningsExact identifier
application number: ANDA077007
rxcui: 359818
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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