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 8 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone nicotineNICOTINE POLACRILEXAmerican Sales Companybe90d633-e928-484c-9fa7-d363c23bb89c2026-06-19WarningsExact identifier
unii: 6M3C89ZY6R
Berkley and Jensen NicotineNICOTINE POLACRILEXBJWCb04f4f1e-55d3-4486-acf1-6a93dc919f2d2026-06-19WarningsExact identifier
unii: 6M3C89ZY6R
berkley and jensen nicotineNICOTINE POLACRILEXBJWC8fdfe95a-8bd9-4a77-a95d-0d373e279a4a2026-06-19WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEH E B08d448f6-7cf1-4725-978a-01dfe7dc07c82026-06-18WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXH E B9c0122e4-7b5b-40c6-a981-1f7853bf3ce72026-06-18WarningsExact identifier
application number: ANDA077007
rxcui: 359818
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC107d6b24-fa5e-4fff-8365-b0b92251708e2026-06-18WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXH E Bc690001d-12c4-4a0f-b9b0-2d2b73dcd93a2026-06-18WarningsExact identifier
unii: 6M3C89ZY6R
COATED NICOTINENICOTINE POLACRILEXPublix Super Markets Inc8868a487-d77b-4c6f-8ef9-5a6fe22ce0ad2026-06-18WarningsExact identifier
unii: 6M3C89ZY6R
care one nicotineNICOTINE POLACRILEXAmerican Sales Companye9558a4e-a0ad-4391-9b9c-85edb61523c12026-06-17WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCcbf094d4-2357-426d-8205-9b59c332854f2026-06-16WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLCc65c1c40-4c8f-40bb-ace4-8bbc9ecf630e2026-06-16WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC4d669f54-5031-4b89-a546-6cdefc648fc32026-06-16WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXPublix Super Markets Inc05f4c92b-1d57-4ef2-a53d-d4069d2730f32026-06-15WarningsExact identifier
unii: 6M3C89ZY6R
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLC56a1c778-fc3b-4848-a7e0-b1e4f0a8fbc22026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXSafewayed4fe766-1329-4d57-894d-3b977dd07b5c2026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
CareOne nicotineNICOTINE POLACRILEXAmerican Sales Companyffaa553c-7323-4d9c-87f4-2846bc51fa7c2026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafeway3591828f-dff0-4cb7-ab0e-d43704243dc22026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E Bbbc4fd9f-b1f5-4691-b980-3424c91e4c882026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B8c288d15-d1ea-42b6-8cfb-f056d59fd3e02026-06-12WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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