CareOne Mini Nicotine Polacrilex

Product NDC
41520-957
11-digit product format
415200957
Labeler code
41520
Product ID
41520-957_2f975f2a-9842-47a6-9fa7-03241c550644
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
American Sales Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-06-22
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CareOne Mini Nicotine Polacrilex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359818

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-957-02CareOne Mini Nicotine Polacrilex27 in 1 CONTAINERLOZENGE275
41520-957-02CareOne Mini Nicotine Polacrilex3 in 1 CARTONLOZENGE35
41520-957-03CareOne Mini Nicotine Polacrilex4 in 1 CARTONLOZENGE45
41520-957-03CareOne Mini Nicotine Polacrilex27 in 1 CONTAINERLOZENGE275

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-957CAREONE MINI NICOTINE POLACRILEX (NICOTINE POLACRILEX) LOZENGE [AMERICAN SALES COMPANY]5Current NDC, Legacy NDC, 4 package rows20231026_d3591f0c-f638-485a-ab34-f71fce6a966f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNd3591f0c-f638-485a-ab34-f71fce6a966f5
359818nicotine 4 MG Oral LozengeSCDd3591f0c-f638-485a-ab34-f71fce6a966f5
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYd3591f0c-f638-485a-ab34-f71fce6a966f5
359818nicotine 4 MG TrocheSYd3591f0c-f638-485a-ab34-f71fce6a966f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-957-02415200957023 CONTAINER in 1 CARTON (41520-957-02) / 27 LOZENGE in 1 CONTAINER3 container2013-08-070000-00-00NoNoCurrent
41520-957-03415200957034 CONTAINER in 1 CARTON (41520-957-03) > 27 LOZENGE in 1 CONTAINER4 container2013-06-220000-00-00NoNoCurrent