FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-5023
11-digit product format
001135023
Labeler code
0113
Product ID
0113-5023_5c89061b-1452-4962-9f25-212f2ae8e41e
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2024-04-18
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
Rxcui359818

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
0113-5023-27Good Sense Nicotine40 in 1 CONTAINERLOZENGE401
0113-5023-27Good Sense Nicotine2 in 1 CARTONLOZENGE21
0113-5023-58Good Sense Nicotine40 in 1 CONTAINERLOZENGE401
0113-5023-60Good Sense Nicotine1 in 1 CARTONLOZENGE11
0113-5023-60Good Sense Nicotine20 in 1 CONTAINERLOZENGE201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-5023GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]1Current NDC, 5 package rows20240503_5c89061b-1452-4962-9f25-212f2ae8e41e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN5c89061b-1452-4962-9f25-212f2ae8e41e1
359818nicotine 4 MG Oral LozengeSCD5c89061b-1452-4962-9f25-212f2ae8e41e1
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY5c89061b-1452-4962-9f25-212f2ae8e41e1
359818nicotine 4 MG TrocheSY5c89061b-1452-4962-9f25-212f2ae8e41e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-5023-27001135023272 CONTAINER in 1 CARTON (0113-5023-27) / 40 LOZENGE in 1 CONTAINER2 container2024-04-18NoNoCurrent
0113-5023-580011350235840 LOZENGE in 1 CONTAINER (0113-5023-58) 40 lozenge2024-04-18NoNoCurrent
0113-5023-60001135023601 CONTAINER in 1 CARTON (0113-5023-60) / 20 LOZENGE in 1 CONTAINER1 container2024-04-18NoNoCurrent