FDA.reportPublic FDA data

good sense nicotine

Product NDC
0113-1352
11-digit product format
001131352
Labeler code
0113
Product ID
0113-1352_947e6dd4-14a4-4b0f-b3de-dd051fa4c26a
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA078547
Marketing category
ANDA
Marketing start
2018-11-29
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
0113-1352-06good sense nicotine1 in 1 BLISTER PACKGUM, CHEWING15
0113-1352-06good sense nicotine160 in 1 CARTONGUM, CHEWING1605
0113-1352-78good sense nicotine100 in 1 CARTONGUM, CHEWING1005
0113-1352-78good sense nicotine1 in 1 BLISTER PACKGUM, CHEWING15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1352-78EA - Each0113-1352cd8810da-a2b2-4a7c-b33f-00309b495d1212023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1352GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]4Current NDC, Legacy NDC, 4 package rows20250328_8647dca6-676b-4279-8e20-17153feb9974.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN8647dca6-676b-4279-8e20-17153feb99745
314119nicotine 2 MG Chewing GumSCD8647dca6-676b-4279-8e20-17153feb99745
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY8647dca6-676b-4279-8e20-17153feb99745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1352-0600113135206160 BLISTER PACK in 1 CARTON (0113-1352-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2025-08-21NoNoCurrent
0113-1352-7800113135278100 BLISTER PACK in 1 CARTON (0113-1352-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2018-11-290000-00-00NoNoCurrent