Nicotine Polacrilex

Product NDC
56062-608
11-digit product format
560620608
Labeler code
56062
Product ID
56062-608_cab3bd48-b5cd-476b-a67c-004fc951034f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
BUCCAL
Labeler
Publix Supermarkets, Inc.
Application
ANDA074507
Marketing category
ANDA
Marketing start
2014-01-01
Substance
NICOTINE
Active strength
2 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 Polacrilex
Brand name suffix
Original Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975, 314119

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
56062-608-62Nicotine PolacrilexOriginal Flavor10 in 1 BLISTER PACKGUM, CHEWING1013
56062-608-62Nicotine PolacrilexOriginal Flavor11 in 1 CARTONGUM, CHEWING1113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-608NICOTINE POLACRILEX ORIGINAL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING NICOTINE POLACRILEX ORIGIANL FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [PUBLIX SUPERMARKETS, INC.]13Current NDC, Legacy NDC, 2 package rows20240731_540c88bd-70dc-416a-8d8e-0a33b2b29563.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN540c88bd-70dc-416a-8d8e-0a33b2b2956313
311975nicotine polacrilex 4 MG Chewing GumPSN540c88bd-70dc-416a-8d8e-0a33b2b2956313
314119nicotine 2 MG Chewing GumSCD540c88bd-70dc-416a-8d8e-0a33b2b2956313
311975nicotine 4 MG Chewing GumSCD540c88bd-70dc-416a-8d8e-0a33b2b2956313
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY540c88bd-70dc-416a-8d8e-0a33b2b2956313
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY540c88bd-70dc-416a-8d8e-0a33b2b2956313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-608-625606206086211 BLISTER PACK in 1 CARTON (56062-608-62) / 10 GUM, CHEWING in 1 BLISTER PACK11 blister pack2014-01-010000-00-00NoNoCurrent