nicotine

Product NDC
41250-689
11-digit product format
412500689
Labeler code
41250
Product ID
41250-689_2faad3c6-f264-4a60-96ba-77265f5af685
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA206393
Marketing category
ANDA
Marketing start
2019-12-18
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
41250-689-06nicotine160 in 1 CARTONGUM, CHEWING1605
41250-689-06nicotine1 in 1 BLISTER PACKGUM, CHEWING15
41250-689-60nicotine20 in 1 CARTONGUM, CHEWING205
41250-689-60nicotine1 in 1 BLISTER PACKGUM, CHEWING15
41250-689-78nicotine100 in 1 CARTONGUM, CHEWING1005
41250-689-78nicotine1 in 1 BLISTER PACKGUM, CHEWING15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-689NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]4Current NDC, Legacy NDC, 6 package rows20250308_860f8306-4cd4-4444-8c6e-182ddeb10ad6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN860f8306-4cd4-4444-8c6e-182ddeb10ad65
311975nicotine 4 MG Chewing GumSCD860f8306-4cd4-4444-8c6e-182ddeb10ad65
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY860f8306-4cd4-4444-8c6e-182ddeb10ad65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-689-0641250068906160 BLISTER PACK in 1 CARTON (41250-689-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2020-01-030000-00-00NoNoCurrent
41250-689-604125006896020 BLISTER PACK in 1 CARTON (41250-689-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2019-12-180000-00-00NoNoCurrent
41250-689-7841250068978100 BLISTER PACK in 1 CARTON (41250-689-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2019-12-210000-00-00NoNoCurrent