FDA.reportPublic FDA data

NDC 41520-734-01 - CareOne 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
41520-734
Requested NDC
41520-734-01
Package NDCs from labels
41520-734-01, 41520-734-02, 41520-734-03
Manufacturer
American Sales Company
Effective date
2026-04-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CareOne Nicotine - American Sales CompanyAmerican Sales Company2026-04-14HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-734-01CareOne Nicotine27 in 1 CONTAINERLOZENGE276
41520-734-02CareOne Nicotine3 in 1 CARTONLOZENGE36
41520-734-03CareOne Nicotine4 in 1 CARTONLOZENGE46
41520-734-03CareOne Nicotine27 in 1 CONTAINERLOZENGE276

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-734CAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 4 package rows20231026_74ec6a60-eb3a-47d4-a11b-650b6418d37f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RCAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RCAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49CAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ACAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SCAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNCAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TCAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECAREONE NICOTINE (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]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 22 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Habitrol Nicotine Polacrilex 2 mg Coated CinnamonNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6874a9f1-d180-4073-8226-df6e21bcf0b72025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Gum 4 mg Coated FruitNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5d3b45d6-97c2-4400-ad09-95a4b21f53242025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex 4 mg Coated CinnamonNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5c394758-1179-455a-a562-c8e954fb22582025-12-23WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON FIBER CAPLETSCALCIUM POLYCARBOPHILAMAZON.COM SERVICES LLC178f4150-c75c-45e1-a5f3-3af67b5c81092025-12-22WarningsExact identifier
unii: 8F049NKY49
Habitrol Nicotine Polacrilex Gum 2 mg Coated MintNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.826f0ce5-9862-4f6f-8943-a3f06b07e69f2025-12-22WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Nicotine Polacrilex Gum 2 mg Coated FruitNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.dc811e89-e104-4fdf-aabf-f73d41d85f4c2025-12-22WarningsExact identifier
unii: 6M3C89ZY6R
L-TransLYMPH SYSTEM BOOSTERVitality Works, Inc.72ccb9be-2d62-414a-856a-7fcea51f26d22025-12-17WarningsExact identifier
unii: 6M3C89ZY6R
Irritable Bowel Syndrome TherapyASAFETIDA - BISMUTH SUBNITRATE - BRYONIA ALBA ROOT - ACTIVATED CHARCOAL - LYCOPODIUM CLAVATUM SPORE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - VERATRUM ALBUM ROOT -TRP Company04149220-c7ce-4312-9630-f93d6def3aaa2025-12-15WarningsExact identifier
unii: 45P3261C7T
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.45a7e1cf-7182-6ec3-e063-6394a90ae4412025-12-11WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXKroger Company69a61101-df32-444e-a49a-eccfeebfb20e2025-12-11WarningsExact identifier
unii: 6M3C89ZY6R
GUHIO Nicotine PatchNICOTINEGuangxi Keyun E-commerce Co., Ltd.45a53cd6-3e3f-697a-e063-6394a90a6c832025-12-10WarningsExact identifier
unii: 6M3C89ZY6R
mini nicotineNICOTINE POLACRILEXMeijer Distribution Inca5528828-cd03-46fc-a13c-3ccae1c0dc5c2025-12-10WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC41ae65b3-2e4e-4306-959d-be44c7d205fe2025-12-10WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 3NICOTINE TRANSDERMAL PATCHESPCHEERY LLC45811e83-8d0b-bc2a-e063-6294a90adf502025-12-09WarningsExact identifier
unii: 6M3C89ZY6R
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 2NICOTINE TRANSDERMAL PATCHESPCHEERY LLC4580d7f0-92a9-d0d0-e063-6394a90ac3932025-12-09WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCf3035ca0-8739-4d77-af97-f6021d6478c22025-12-09WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC6b500780-f45c-477c-8371-3b60e33050002025-12-08WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1NICOTINE TRANSDERMAL PATCHESPCHEERY LLC457c860b-091d-8350-e063-6294a90a2f982025-12-08WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXMeijer, Inc.084f9d77-b4ab-4328-8ff4-cdc7523daebe2025-12-08WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXRising Pharma Holdings, Inc.05990040-5bd7-4622-8fe3-2d7573904dfa2025-12-06WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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