careone nicotine

Product NDC
41520-843
11-digit product format
415200843
Labeler code
41520
Product ID
41520-843_7200e887-24c1-43ec-ac90-18fdddc2d29e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
American Sales Company
Application
ANDA206393
Marketing category
ANDA
Marketing start
2017-09-29
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 nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-843-60careone nicotine1 in 1 BLISTER PACKGUM, CHEWING13
41520-843-60careone nicotine20 in 1 CARTONGUM, CHEWING203
41520-843-78careone nicotine1 in 1 BLISTER PACKGUM, CHEWING13
41520-843-78careone nicotine100 in 1 CARTONGUM, CHEWING1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-843CAREONE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [AMERICAN SALES COMPANY]3Current NDC, Legacy NDC, 4 package rows20250515_be90d633-e928-484c-9fa7-d363c23bb89c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNbe90d633-e928-484c-9fa7-d363c23bb89c3
311975nicotine 4 MG Chewing GumSCDbe90d633-e928-484c-9fa7-d363c23bb89c3
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYbe90d633-e928-484c-9fa7-d363c23bb89c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-843-604152008436020 BLISTER PACK in 1 CARTON (41520-843-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2017-09-290000-00-00NoNoCurrent
41520-843-7841520084378100 BLISTER PACK in 1 CARTON (41520-843-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2017-09-290000-00-00NoNoCurrent