FDA.reportPublic FDA data

Nicotine

Product NDC
41250-854
11-digit product format
412500854
Labeler code
41250
Product ID
41250-854_04e16c8d-0fd6-4b68-8316-e392b3dd502e
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA078546
Marketing category
ANDA
Marketing start
1992-02-21
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
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
41250-854-06Nicotine160 in 1 CARTONGUM, CHEWING1609
41250-854-06Nicotine1 in 1 BLISTER PACKGUM, CHEWING19
41250-854-60Nicotine20 in 1 CARTONGUM, CHEWING209
41250-854-60Nicotine1 in 1 BLISTER PACKGUM, CHEWING19
41250-854-76Nicotine120 in 1 CARTONGUM, CHEWING1209
41250-854-76Nicotine1 in 1 BLISTER PACKGUM, CHEWING19
41250-854-78Nicotine100 in 1 CARTONGUM, CHEWING1009
41250-854-78Nicotine1 in 1 BLISTER PACKGUM, CHEWING19

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
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
GELATININACTIVE INGREDIENT2G86QN327LNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE (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
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-854NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]9Current NDC, Legacy NDC, 8 package rows20231207_59ba5cba-be1e-4708-a9ab-01f43543bb5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN59ba5cba-be1e-4708-a9ab-01f43543bb5b9
311975nicotine 4 MG Chewing GumSCD59ba5cba-be1e-4708-a9ab-01f43543bb5b9
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY59ba5cba-be1e-4708-a9ab-01f43543bb5b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-854-0641250085406160 BLISTER PACK in 1 CARTON (41250-854-06) > 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2018-08-060000-00-00NoNoCurrent
41250-854-604125008546020 BLISTER PACK in 1 CARTON (41250-854-60) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2018-10-020000-00-00NoNoCurrent
41250-854-7641250085476120 BLISTER PACK in 1 CARTON (41250-854-76) / 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2009-08-210000-00-00NoNoCurrent
41250-854-7841250085478100 BLISTER PACK in 1 CARTON (41250-854-78) > 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2007-09-260000-00-00NoNoCurrent