FDA.reportPublic FDA data

care one nicotine

Product NDC
41520-352
11-digit product format
415200352
Labeler code
41520
Product ID
41520-352_ceb2c70e-6359-4abd-b916-81eb8d691578
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
American Sales Company
Application
ANDA078547
Marketing category
ANDA
Marketing start
2008-08-29
Substance
NICOTINE
Active strength
2 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
care one nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

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
41520-352-78care one nicotine1 in 1 BLISTER PACKGUM, CHEWING17
41520-352-78care one nicotine100 in 1 CARTONGUM, CHEWING1007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
NICOTINEACTIVE MOIETY6M3C89ZY6RCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
GELATININACTIVE INGREDIENT2G86QN327LCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ACARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ECARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-352CARE ONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]7Current NDC, Legacy NDC, 2 package rows20250328_e9558a4e-a0ad-4391-9b9c-85edb61523c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNe9558a4e-a0ad-4391-9b9c-85edb61523c17
314119nicotine 2 MG Chewing GumSCDe9558a4e-a0ad-4391-9b9c-85edb61523c17
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYe9558a4e-a0ad-4391-9b9c-85edb61523c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-352-7841520035278100 BLISTER PACK in 1 CARTON (41520-352-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2017-09-290000-00-00NoNoCurrent