FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-0456
11-digit product format
001130456
Labeler code
0113
Product ID
0113-0456_c5889d9d-424d-4b2e-89bd-d990f07f1e84
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA076777
Marketing category
ANDA
Marketing start
2007-03-07
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
Good Sense 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
0113-0456-06Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING17
0113-0456-06Good Sense Nicotine160 in 1 CARTONGUM, CHEWING1607
0113-0456-60Good Sense Nicotine20 in 1 CARTONGUM, CHEWING207
0113-0456-60Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING17
0113-0456-78Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING17
0113-0456-78Good Sense Nicotine100 in 1 CARTONGUM, CHEWING1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0456GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]6Current NDC, Legacy NDC, 6 package rows20250303_74ce5bd9-98ad-4e41-80b0-5d7aaa122ac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN74ce5bd9-98ad-4e41-80b0-5d7aaa122ac87
314119nicotine 2 MG Chewing GumSCD74ce5bd9-98ad-4e41-80b0-5d7aaa122ac87
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY74ce5bd9-98ad-4e41-80b0-5d7aaa122ac87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0456-0600113045606160 BLISTER PACK in 1 CARTON (0113-0456-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2026-02-20NoNoCurrent
0113-0456-600011304566020 BLISTER PACK in 1 CARTON (0113-0456-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2013-05-230000-00-00NoNoCurrent
0113-0456-78001130456781 in 1 BLISTER PACKHistorical