FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-2502
11-digit product format
001132502
Labeler code
0113
Product ID
0113-2502_2ad48d3a-64a0-4428-86ad-0899b5952e37
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2024-03-21
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
Rxcui359817

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-2502-27Good Sense Nicotine2 in 1 CARTONLOZENGE22
0113-2502-58Good Sense Nicotine40 in 1 CONTAINERLOZENGE402
0113-2502-60Good Sense Nicotine20 in 1 CONTAINERLOZENGE202
0113-2502-60Good Sense Nicotine1 in 1 CARTONLOZENGE12
0113-2502-76Good Sense Nicotine3 in 1 CARTONLOZENGE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-2502GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]1Current NDC, 5 package rows20240406_0ac7f87a-63f4-4d74-ba5b-d1444803b100.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN0ac7f87a-63f4-4d74-ba5b-d1444803b1002
359817nicotine 2 MG Oral LozengeSCD0ac7f87a-63f4-4d74-ba5b-d1444803b1002
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY0ac7f87a-63f4-4d74-ba5b-d1444803b1002
359817nicotine 2 MG TrocheSY0ac7f87a-63f4-4d74-ba5b-d1444803b1002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-2502-27001132502272 CONTAINER in 1 CARTON (0113-2502-27) / 40 LOZENGE in 1 CONTAINER (0113-2502-58) 2 container2024-03-27NoNoHistorical
0113-2502-580011325025840 in 1 CONTAINERHistorical
0113-2502-60001132502601 CONTAINER in 1 CARTON (0113-2502-60) / 20 LOZENGE in 1 CONTAINER1 container2024-03-21NoNoHistorical
0113-2502-76001132502763 CONTAINER in 1 CARTON (0113-2502-76) / 40 LOZENGE in 1 CONTAINER (0113-2502-58) 3 container2026-02-26NoNoHistorical