FDA.reportPublic FDA data

NDC 36800-375-03 - topcare 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
36800-375
Requested NDC
36800-375-03
Package NDCs from labels
36800-375-03, 36800-375-05
Manufacturer
Topco Associates LLC
Effective date
2026-02-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
topcare nicotine polacrilex - Topco Associates LLCTopco Associates LLC2026-02-11HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-375-03topcare nicotine polacrilex24 in 1 CONTAINERLOZENGE246
36800-375-05topcare nicotine polacrilex3 in 1 CARTONLOZENGE36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-375TOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 2 package rows20181120_d0403746-f866-42da-ad66-2a686c8bce01.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RTOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
NICOTINEACTIVE MOIETY6M3C89ZY6RTOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9TOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ATOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
POLACRILININACTIVE INGREDIENTRCZ785HI7STOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNTOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQTOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TTOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCARE NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2

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 3 of 37 · 737 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense nicotineNICOTINE POLACRILEXL. Perrigo Companyeefcb8f8-4334-4e75-8e52-ef1ffbf3f0a92026-08-04WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLC634e50f9-92bb-43be-bd90-360d67d174eb2026-08-04WarningsExact identifier
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC48230756-9448-4957-82a6-5e7e3c2c0b572026-08-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AID Step1NICOTINE 21 MGGuangxi Keyun E-commerce Co., Ltd.57a7a614-5f23-258b-e063-6294a90a94b12026-07-28WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AID Step2NICOTINE 14 MGGuangxi Keyun E-commerce Co., Ltd.57a8a71b-7213-ab7d-e063-6394a90a51302026-07-28WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Stop Smoking AID Step3NICOTINE 7 MGGuangxi Keyun E-commerce Co., Ltd.57a8b8d3-0acc-bf91-e063-6294a90a99f82026-07-28WarningsExact identifier
unii: 6M3C89ZY6R
SERYNTH NICOTINE TRANSDERMAL STOP SMOKING AIDNICOTINE21MG NICOTINE TRANSDERMAL STOP SMOKING AIDJiangxi Yudexi Pharmaceutical Co., LTD4d5821f9-605e-5391-e063-6294a90afcd22026-07-24WarningsExact identifier
unii: 6M3C89ZY6R
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporationcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b2026-07-24WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc4ddba70a-3f45-4c76-a12a-6da256e9afc52026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCc6c9582c-004d-4925-b147-add5f28f38562026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS Pharmacyab1407e3-9092-438c-b684-8194e4ee71af2026-07-23WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Up and Up NicotineNICOTINE POLACRILEXTarget Corporationa4bf013b-286b-486c-bb8f-2defb3881d4c2026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Incecdfe02c-813b-4c1e-9e02-d7c544a896442026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Incfd93fdf4-fa48-4373-aac7-894866a0b18d2026-07-22WarningsExact identifier
unii: 6M3C89ZY6R
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
unii: 6M3C89ZY6R
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
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc31b1a48e-8651-41d7-b693-6509a344906a2026-07-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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