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#

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#

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 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen NICOTINENICOTINE POLACRILEXBJWCcdaa2643-7630-41e8-bd48-4a760cf4a46a2026-06-19WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEH E Bda70bf12-4454-40ac-8cfd-8b7697496d552026-06-19WarningsExact identifier
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafewayda824d13-9dfa-41e5-a6ac-0081f5de74a82026-06-19WarningsExact identifier
unii: 6M3C89ZY6R
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
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

Reported adverse events (FAERS/openFDA)#

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