FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-0170
11-digit product format
001130170
Labeler code
0113
Product ID
0113-0170_23d0649a-244b-4838-897c-b6c9917c3780
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA076789
Marketing category
ANDA
Marketing start
2005-05-06
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
0113-0170-25Good Sense Nicotine110 in 1 CARTONGUM, CHEWING11010
0113-0170-25Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
0113-0170-29Good Sense Nicotine220 in 1 CARTONGUM, CHEWING22010
0113-0170-29Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
0113-0170-60Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING110
0113-0170-60Good Sense Nicotine20 in 1 CARTONGUM, CHEWING2010
0113-0170-71Good Sense Nicotine50 in 1 CARTONGUM, CHEWING5010
0113-0170-71Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0170GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]9Current NDC, Legacy NDC, 8 package rows20250321_ae802de5-8e1b-439f-ab81-db4bd7241c91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNae802de5-8e1b-439f-ab81-db4bd7241c9110
311975nicotine 4 MG Chewing GumSCDae802de5-8e1b-439f-ab81-db4bd7241c9110
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYae802de5-8e1b-439f-ab81-db4bd7241c9110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0170-2500113017025110 BLISTER PACK in 1 CARTON (0113-0170-25) > 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2020-04-150000-00-00NoNoCurrent
0113-0170-2900113017029220 BLISTER PACK in 1 CARTON (0113-0170-29) / 1 GUM, CHEWING in 1 BLISTER PACK220 blister pack2026-01-29NoNoCurrent
0113-0170-600011301706020 BLISTER PACK in 1 CARTON (0113-0170-60) > 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2005-05-060000-00-00NoNoCurrent
0113-0170-710011301707150 BLISTER PACK in 1 CARTON (0113-0170-71) / 1 GUM, CHEWING in 1 BLISTER PACK50 blister pack2018-12-300000-00-00NoNoCurrent