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 2 of 38 · 750 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXWalgreens97ce52b1-d98e-4216-99c2-7e341c8fec432026-08-25WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmazon.com Services LLC4ab742f2-2599-4d9f-83c5-9338d66ad6cf2026-08-24WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCardinal Health 107, LLCebab2c3a-4fda-40d6-8f54-972e1c6ee69a2026-08-24WarningsExact identifier
unii: 6M3C89ZY6R
Quit smoking patchesQUIT SMOKING PATCHESShenzhen yuehaotong Technology Co., Ltd59b0c0e9-dc03-ec1e-e063-6394a90a8a872026-08-23WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCb957f757-2b34-49b2-a68b-a7bc9e8dd8b22026-08-21WarningsExact identifier
unii: 6M3C89ZY6R
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXWalgreen Company5dd116ea-d031-439c-b06c-2f77230bc4462026-08-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXAmazon.com Services LLCe40a534e-8083-454d-9667-826bfbac397c2026-08-19WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXAmazon.com Services LLCbc1b6b41-d069-470e-90ca-a441ab97f96a2026-08-18WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXWALMART INC. (see also Equate)286e2768-ad98-43be-a3be-a2db0370f50f2026-08-12WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXWALMART INC. (see also Equate)b49546cd-6cc4-422c-9a72-3a1faf2abcd32026-08-12WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122a33b6ed6-2c75-4bab-98e5-a7f8bea219262026-08-12WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: 45P3261C7T
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsExact identifier
unii: 6M3C89ZY6R
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC1f93571c-4bd2-4272-ab9f-240b7c8a024b2026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC4cc32b8c-6316-4d4b-8fa9-ef640464ca692026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
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
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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