FDA.reportPublic FDA data

Nicotine

Product NDC
41250-456
11-digit product format
412500456
Labeler code
41250
Product ID
41250-456_d06119b1-1c60-4a98-9f45-64c5f3e7314a
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA076777
Marketing category
ANDA
Marketing start
2006-10-31
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
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
41250-456-06Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
41250-456-06Nicotine160 in 1 CARTONGUM, CHEWING16010
41250-456-58Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
41250-456-58Nicotine40 in 1 CARTONGUM, CHEWING4010
41250-456-60Nicotine20 in 1 CARTONGUM, CHEWING2010
41250-456-60Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
41250-456-70Nicotine240 in 1 CARTONGUM, CHEWING24010
41250-456-70Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
41250-456-76Nicotine120 in 1 CARTONGUM, CHEWING12010
41250-456-76Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
41250-456-78Nicotine100 in 1 CARTONGUM, CHEWING10010
41250-456-78Nicotine1 in 1 BLISTER PACKGUM, CHEWING110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-456NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]9Current NDC, Legacy NDC, 12 package rows20250305_6d86cb8f-018e-41be-a6d0-9ca30e731855.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN6d86cb8f-018e-41be-a6d0-9ca30e73185510
314119nicotine 2 MG Chewing GumSCD6d86cb8f-018e-41be-a6d0-9ca30e73185510
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY6d86cb8f-018e-41be-a6d0-9ca30e73185510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-456-0641250045606160 BLISTER PACK in 1 CARTON (41250-456-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2007-05-040000-00-00NoNoCurrent
41250-456-58412500456581 in 1 BLISTER PACKHistorical
41250-456-604125004566020 BLISTER PACK in 1 CARTON (41250-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2014-06-200000-00-00NoNoCurrent
41250-456-7041250045670240 BLISTER PACK in 1 CARTON (41250-456-70) / 1 GUM, CHEWING in 1 BLISTER PACK240 blister pack2011-06-030000-00-00NoNoCurrent
41250-456-7641250045676120 BLISTER PACK in 1 CARTON (41250-456-76) / 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2007-11-070000-00-00NoNoCurrent
41250-456-7841250045678100 BLISTER PACK in 1 CARTON (41250-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2006-10-310000-00-00NoNoCurrent