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 37 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier
unii: 6M3C89ZY6R
Natrum carbonicumSODIUM CARBONATEBoiron864414b8-9568-7580-e053-2a91aa0a231d2023-01-05Exact identifier
unii: 45P3261C7T
Natrum carbonicumSODIUM CARBONATEBoiron8644c5d1-4db3-fac8-e053-2a91aa0a8d6d2023-01-05Exact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0315c9e-8922-c0b5-e053-2a95a90ae54e2022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f031e256-fca5-3939-e053-2995a90a4fe62022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f0328097-e5d2-3532-e053-2a95a90a93f02022-12-19WarningsExact identifier
unii: 45P3261C7T
WartsANTIMON. CRUD., BRYONIA, CALC.CARB., CAUSTICUM, DULCAMARA, GRAPHITES, LYCOPODIUM, MERC. SULPH. RUB., NAT. CARB., NITRICUM AC., NUX VOM., RHUS TOXICODENDRON, SABINA, SEPIA, SILICEA, STAPHYSAG., SULPHUR, THUJA OCC., TARAXACUMNewton Laboratories, Inc.f032e7bb-a6fd-2951-e053-2a95a90a8c3a2022-12-19WarningsExact identifier
unii: 45P3261C7T
MUNDIPURBRYONIA DIOICA ROOT, COLCHICUM AUTUMNALE BULB, SODIUM CARBONATE, PHYTOLACCA AMERICANA ROOT, BERBERIS VULGARIS ROOT BARK, CYNARA SCOLYMUS WHOLE, HARPAGOPHYTUM PROCUMBENS ROOT, AND LEDUM PALUSTRE TWIGPEKANA Naturheilmittel GmbH4aeba0c8-0d53-4012-8024-df1e82585cb32022-12-16WarningsExact identifier
unii: 45P3261C7T
Nicotine MiniNICOTINE POLACRILEXEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)4eeaf22c-a839-49c5-b099-77321d590d062022-12-06WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc8c66eb21-dd95-4dcb-8488-e1e768dd8cd62022-12-06WarningsExact identifier
application number: ANDA203690
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy4853ee32-521f-4359-8084-438893be43bc2022-11-22WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCVS Pharmacy7fa848c6-3a4a-41f3-b927-1b26b6232e3a2022-11-22WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy8332bb07-72a7-491e-a19b-baff84acefdb2022-11-22WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafewaycb2624de-3908-4091-aea1-f0dc76abd6332022-11-15WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Natrum CarbonicumNATRUM CARBONICUMHahnemann Laboratories, INC.ecee3632-9ca1-6e93-e053-2a95a90afb582022-11-07Exact identifier
unii: 45P3261C7T
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC85f05cc6-ae2e-4338-8c1e-c681c2f908582022-11-03WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIAurohealth LLCcfe6fb63-2897-4e76-8288-1389f363b3c42022-11-03WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 7000071ee5a44-b451-4ecd-9fe7-8124b4dae1c52022-10-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 700006edf8c50-d3b9-469a-ad57-37c05e0988622022-10-20WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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