FDA.reportPublic FDA data

UP AND UP COATED MINT FREEZE NICOTINE

Product NDC
82442-100
11-digit product format
824420100
Labeler code
82442
Product ID
82442-100_3708859f-dbc8-41b5-919d-9db9b3b3b284
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Target Corporation
Application
ANDA206394
Marketing category
ANDA
Marketing start
2024-05-01
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
UP AND UP COATED MINT FREEZE 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
82442-100-06UP AND UP COATED MINT FREEZE NICOTINE1 in 1 BLISTER PACKGUM, CHEWING13
82442-100-06UP AND UP COATED MINT FREEZE NICOTINE160 in 1 CARTONGUM, CHEWING1603
82442-100-60UP AND UP COATED MINT FREEZE NICOTINE20 in 1 CARTONGUM, CHEWING203
82442-100-60UP AND UP COATED MINT FREEZE NICOTINE1 in 1 BLISTER PACKGUM, CHEWING13
82442-100-78UP AND UP COATED MINT FREEZE NICOTINE1 in 1 BLISTER PACKGUM, CHEWING13
82442-100-78UP AND UP COATED MINT FREEZE NICOTINE100 in 1 CARTONGUM, CHEWING1003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNf14c065e-88bc-4fba-8a70-51e140afeb373
314119nicotine 2 MG Chewing GumSCDf14c065e-88bc-4fba-8a70-51e140afeb373
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYf14c065e-88bc-4fba-8a70-51e140afeb373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82442-100-0682442010006160 BLISTER PACK in 1 CARTON (82442-100-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2024-05-01NoNoHistorical
82442-100-608244201006020 BLISTER PACK in 1 CARTON (82442-100-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2024-05-02NoNoHistorical
82442-100-7882442010078100 BLISTER PACK in 1 CARTON (82442-100-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2024-05-01NoNoHistorical