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 35 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum carbonicumSODIUM CARBONATEBoiron87fddb6a-d890-78a5-e053-2a95a90ac2aa2023-11-14Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron81bf8b10-7c5f-11e6-8655-424c583030312023-11-14Exact identifier
unii: 45P3261C7T
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.99eb7b5d-926d-aa16-e053-2a95a90a08342023-11-07WarningsExact identifier
unii: 45P3261C7T
GOOD SENSENICOTINE POLACRILEXA-S Medication Solutionsdece0a8d-a7df-446f-bfcf-9f96e8bfc4ae2023-10-31WarningsExact identifier
unii: 6M3C89ZY6R
Fiber LaxativeCALCIUM POLYCARBOPHILMagno-Humphries, Inc.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
unii: 8F049NKY49
CareOne Mini Nicotine PolacrilexNICOTINE POLACRILEXAmerican Sales Companyd3591f0c-f638-485a-ab34-f71fce6a966f2023-10-25WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC7eed43bd-b26c-41cd-b2bc-74d6c15b376c2023-10-25WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4856d5df-3b77-465e-b6a9-38d00854f9672023-10-23WarningsExact identifier
unii: 6M3C89ZY6R
care one nicotineNICOTINE POLACRILEXAmerican Sales Company1b6be939-cd9d-4ab4-b291-096cf498cf922023-10-20WarningsExact identifier
unii: 6M3C89ZY6R
careone nicotineNICOTINE POLACRILEXAmerican Sales Company84ed0acf-dcd3-4d4a-8e5c-f75f48993b342023-10-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC4547ec2b-1543-4ce3-bdde-c0b292cdfcc12023-10-16WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC60420337-ce44-403e-943f-2a7964e733062023-10-16WarningsExact identifier
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC5fa9ffff-1511-474b-8342-f366b397de092023-10-13WarningsExact identifier
unii: 6M3C89ZY6R
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: TTV12P4NEE
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: TTV12P4NEE
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: TTV12P4NEE
euqate nicotineNICOTINE POLACRILEXWALMART INC.c1764aad-1da4-4e4e-b6b0-5a3df1edda852023-08-31WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCVS Pharmacye23ad78b-f151-44bb-8dfd-7e933c0d11522023-08-30WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCa0ceda92-78e7-417f-adfc-a085f9b185842023-08-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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