GOOD SENSE NICOTINE

Product NDC
0113-4111
11-digit product format
001134111
Labeler code
0113
Product ID
0113-4111_8823c7a9-22b3-492b-b72d-70e7cb1a3f47
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA206393
Marketing category
ANDA
Marketing start
2026-01-23
Substance
NICOTINE
Active strength
4 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
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
0113-4111-06GOOD SENSE NICOTINE160 in 1 CARTONGUM, CHEWING1601
0113-4111-06GOOD SENSE NICOTINE1 in 1 BLISTER PACKGUM, CHEWING11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN8823c7a9-22b3-492b-b72d-70e7cb1a3f471
311975nicotine 4 MG Chewing GumSCD8823c7a9-22b3-492b-b72d-70e7cb1a3f471
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY8823c7a9-22b3-492b-b72d-70e7cb1a3f471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-4111-0600113411106160 BLISTER PACK in 1 CARTON (0113-4111-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2026-01-23NoNoCurrent