GOOD SENSE NICOTINE

Product NDC
0113-7031
11-digit product format
001137031
Labeler code
0113
Product ID
0113-7031_357240fd-adc0-420a-bf79-8f2eef2bc5da
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2026-01-02
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
Rxcui359818

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
0113-7031-14GOOD SENSE NICOTINE5 in 1 CARTONLOZENGE51
0113-7031-27GOOD SENSE NICOTINE27 in 1 CONTAINERLOZENGE271

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN357240fd-adc0-420a-bf79-8f2eef2bc5da1
359818nicotine 4 MG Oral LozengeSCD357240fd-adc0-420a-bf79-8f2eef2bc5da1
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY357240fd-adc0-420a-bf79-8f2eef2bc5da1
359818nicotine 4 MG TrocheSY357240fd-adc0-420a-bf79-8f2eef2bc5da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0113-7031-14001137031145 CONTAINER in 1 CARTON (0113-7031-14) / 27 LOZENGE in 1 CONTAINER (0113-7031-27) 5 container2026-01-02NoNoHistorical
0113-7031-270011370312727 in 1 CONTAINERHistorical