nicotine

Product NDC
41250-422
11-digit product format
412500422
Labeler code
41250
Product ID
41250-422_6ac5444c-199a-49ca-bcde-585f38e73fcf
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA078326
Marketing category
ANDA
Marketing start
2005-01-24
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
Brand name suffix
mint flavor
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-422-25nicotinemint flavor110 in 1 CARTONGUM, CHEWING1106
41250-422-25nicotinemint flavor1 in 1 BLISTER PACKGUM, CHEWING16
41250-422-29nicotinemint flavor1 in 1 BLISTER PACKGUM, CHEWING16
41250-422-29nicotinemint flavor220 in 1 CARTONGUM, CHEWING2206
41250-422-96nicotinemint flavor170 in 1 CARTONGUM, CHEWING1706
41250-422-96nicotinemint flavor1 in 1 BLISTER PACKGUM, CHEWING16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-422NICOTINE MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [MEIJER DISTRIBUTION INC]6Current NDC, Legacy NDC, 6 package rows20210409_fc38e37e-cfab-46e8-9ead-b56c193b4d42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNfc38e37e-cfab-46e8-9ead-b56c193b4d426
311975nicotine 4 MG Chewing GumSCDfc38e37e-cfab-46e8-9ead-b56c193b4d426
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYfc38e37e-cfab-46e8-9ead-b56c193b4d426

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-422-2541250042225110 in 1 CARTONHistorical
41250-422-2941250042229220 BLISTER PACK in 1 CARTON (41250-422-29) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2011-06-030000-00-00NoNoCurrent
41250-422-9641250042296170 BLISTER PACK in 1 CARTON (41250-422-96) > 1 GUM, CHEWING in 1 BLISTER PACK170 blister pack2005-01-240000-00-00NoNoCurrent