FDA.reportPublic FDA data

nicotine

Product NDC
41250-029
11-digit product format
412500029
Labeler code
41250
Product ID
41250-029_36362e3e-34dc-49b4-a126-91f29a204b5b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA076775
Marketing category
ANDA
Marketing start
2005-02-06
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine
Listing expiration
2027-12-31

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
41250-029-25nicotine110 in 1 CARTONGUM, CHEWING1108
41250-029-25nicotine1 in 1 BLISTER PACKGUM, CHEWING18
41250-029-29nicotine1 in 1 BLISTER PACKGUM, CHEWING18
41250-029-29nicotine220 in 1 CARTONGUM, CHEWING2208
41250-029-96nicotine170 in 1 CARTONGUM, CHEWING1708
41250-029-96nicotine1 in 1 BLISTER PACKGUM, CHEWING18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-029NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]7Current NDC, Legacy NDC, 6 package rows20250328_db0d922a-407f-49ac-b5d3-acc7112a373e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNdb0d922a-407f-49ac-b5d3-acc7112a373e8
314119nicotine 2 MG Chewing GumSCDdb0d922a-407f-49ac-b5d3-acc7112a373e8
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYdb0d922a-407f-49ac-b5d3-acc7112a373e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-029-2541250002925110 in 1 CARTONHistorical
41250-029-2941250002929220 BLISTER PACK in 1 CARTON (41250-029-29) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2019-04-240000-00-00NoNoCurrent
41250-029-9641250002996170 BLISTER PACK in 1 CARTON (41250-029-96) / 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2005-02-060000-00-00NoNoCurrent