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 24 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc27c579b5-1021-4551-9680-bf8978e1d9b42025-11-18WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems, Inc.55442645-fa9b-4a9b-81e2-345ad062a1242025-11-18WarningsExact identifier
unii: 6M3C89ZY6R
STPSMK QUIT SMOKING NICOTINE PATCHESNICOTINEGuangzhou Ouruisi Biotechnology Co., Ltd43c1b4e9-39ee-d398-e063-6394a90a71f02025-11-16WarningsExact identifier
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC17b00f7a-50ac-46ac-b172-6c6c35e9ca7b2025-11-15WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
members mark NicotineNICOTINE POLACRILEXSam's West Incc31c30b9-7431-4b90-b011-f34e499df1922025-11-15WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
nicotineNICOTINE POLACRILEXWalgreen Companyb1154b04-b3a6-4af9-a933-486c5501d46e2025-11-11WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Calcium PolycarbophilCALCIUM POLYCARBOPHILLEADER/ Cardinal Health 110, Inc.b4637e18-c65f-0e81-e053-2a95a90a22842025-11-06WarningsExact identifier
unii: 8F049NKY49
up and up fiber therapyCALCIUM POLYCARBOPHILTarget Corporation.e5473950-06f4-4ea4-975b-3ac94957e7762025-11-04WarningsExact identifier
unii: 8F049NKY49
MedlineNICOTINEMedline Industries, LPe11a4b7e-6f1f-24db-e053-2a95a90a0d092025-11-04WarningsExact identifier
unii: 6M3C89ZY6R
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Fiber CapletsCALCIUM POLYCARBOPHILSAFEWAY08e2e8b0-90b3-48d6-a72a-40688c74771a2025-10-29WarningsExact identifier
unii: 8F049NKY49
PUBLIXCALCIUM POLYCARBOPHILPUBLIX SUPER MARKETS, INC02e3f4ce-8961-425c-98a9-3b9d66709ca52025-10-28WarningsExact identifier
unii: 8F049NKY49
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NicotineNICOTINE POLACRILEXCVS Pharmacy794606a1-12e7-405e-81b2-33ce3fd618322025-10-21WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
unii: 8F049NKY49
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.414217c1-ff3a-b556-e063-6394a90aa5db2025-10-16WarningsExact identifier
unii: 6M3C89ZY6R
WOFANLI Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.41422d04-160b-51b2-e063-6294a90ab2b22025-10-16WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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