FDA.reportPublic FDA data

NDC 36800-957-01 - Topcare Nicotine

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
36800-957
Requested NDC
36800-957-01
Package NDCs from labels
36800-957-01, 36800-957-02, 36800-957-04, 36800-957-60
Manufacturer
Topco Associates LLC
Effective date
2026-02-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Topcare Nicotine - Topco Associates LLCTopco Associates LLC2026-02-16HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-957-022026-01-29C16284748780-149896155-c78b-586f-e063-e6dba90add90Topco Associates LLC. Nicotine Lozenge Drug Facts
36800-957-042026-01-29C16284748780-149896155-c78b-586f-e063-e6dba90add90Topco Associates LLC. Nicotine Lozenge Drug Facts
36800-957-602026-01-29C16284748780-149896155-c78b-586f-e063-e6dba90add90Topco Associates LLC. Nicotine Lozenge Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-957-01Topcare Nicotine27 in 1 CONTAINERLOZENGE276
36800-957-02Topcare Nicotine3 in 1 CARTONLOZENGE36
36800-957-04Topcare Nicotine5 in 1 CARTONLOZENGE56
36800-957-04Topcare Nicotine27 in 1 CONTAINERLOZENGE276
36800-957-60Topcare Nicotine20 in 1 CONTAINERLOZENGE206
36800-957-60Topcare Nicotine1 in 1 CARTONLOZENGE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-957TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]5Current NDC, Legacy NDC, 6 package rows20210511_9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-957-02EA - Each36800-9579713b199-b4fe-4e65-89d9-2a3a815a5d6812024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RTOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
NICOTINEACTIVE MOIETY6M3C89ZY6RTOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ATOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
POLACRILININACTIVE INGREDIENTRCZ785HI7STOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNTOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQTOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TTOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4TOPCARE NICOTINE (NICOTINE POLACRILEX) LOZENGE [TOPCO ASSOCIATES LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETOPCARE NICOTINE (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 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oneoo Nicotine Gum (Mint)NICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.54b1329b-b422-29a5-e063-6294a90a87802026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXP & L Development, LLC3623455a-3f00-41d3-b17e-86a016da70472026-08-06WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC10e3e1ac-2f78-4ce4-8f38-a283fac996602026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecd78195-2df2-401d-b590-2c1cb764df5c2026-08-05WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf97d6b-6ca7-48c1-8c37-029421689cc12026-08-05WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS Pharmacycb9189d6-0593-426d-8ff5-357a4c9180f62026-08-05WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
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
application number: ANDA203690
rxcui: 359818
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
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
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

Reported adverse events (FAERS/openFDA)#

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