Good Sense Nicotine

Product NDC
0113-0053
11-digit product format
001130053
Labeler code
0113
Product ID
0113-0053_902860bf-7d0f-433b-95ea-fae6e953ab07
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
2017-04-27
Substance
NICOTINE
Active strength
4 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
Good Sense Nicotine
Listing expiration
2026-12-31

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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0053-06Good Sense Nicotine1 in 1 BLISTER PACKGUM, CHEWING12
0113-0053-06Good Sense Nicotine160 in 1 CARTONGUM, CHEWING1602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0053-06EA - Each0113-00539a7e8e90-6e23-4c6a-8a85-4a9af68b945c12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0053GOOD SENSE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20210401_fac52e0d-7a02-451e-a36b-30d49e929d3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNfac52e0d-7a02-451e-a36b-30d49e929d3e2
311975nicotine 4 MG Chewing GumSCDfac52e0d-7a02-451e-a36b-30d49e929d3e2
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYfac52e0d-7a02-451e-a36b-30d49e929d3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0053-0600113005306160 BLISTER PACK in 1 CARTON (0113-0053-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2017-04-270000-00-00NoNoCurrent