FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-0734
11-digit product format
001130734
Labeler code
0113
Product ID
0113-0734_d653d9ea-04f7-46eb-a74a-ee8a5e0d3ba0
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-04-22
Substance
NICOTINE
Active strength
2 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
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
0113-0734-01Good Sense Nicotine27 in 1 CONTAINERLOZENGE277
0113-0734-02Good Sense Nicotine3 in 1 CARTONLOZENGE37
0113-0734-03Good Sense Nicotine27 in 1 CONTAINERLOZENGE277
0113-0734-03Good Sense Nicotine4 in 1 CARTONLOZENGE47
0113-0734-04Good Sense Nicotine5 in 1 CARTONLOZENGE57
0113-0734-07Good Sense Nicotine8 in 1 CARTONLOZENGE87
0113-0734-60Good Sense Nicotine20 in 1 CONTAINERLOZENGE207
0113-0734-60Good Sense Nicotine1 in 1 CARTONLOZENGE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0734-02EA - Each0113-0734a61a3094-4524-4522-ba7d-9027cfb4313b12017-12-14
0113-0734-60EA - Each0113-0734980ddbf2-f0b6-4e63-b400-73877b9bee2c12023-01-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
POLACRILININACTIVE INGREDIENTRCZ785HI7SGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0734GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]6Current NDC, Legacy NDC, 8 package rows20240702_477689fc-688a-4c76-8c02-35a7a15adc5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSN477689fc-688a-4c76-8c02-35a7a15adc5e7
359817nicotine 2 MG Oral LozengeSCD477689fc-688a-4c76-8c02-35a7a15adc5e7
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY477689fc-688a-4c76-8c02-35a7a15adc5e7
359817nicotine 2 MG TrocheSY477689fc-688a-4c76-8c02-35a7a15adc5e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0734-010011307340127 in 1 CONTAINERHistorical
0113-0734-02001130734023 CONTAINER in 1 CARTON (0113-0734-02) / 27 LOZENGE in 1 CONTAINER (0113-0734-01) 3 container2013-04-220000-00-00NoNoCurrent
0113-0734-03001130734034 CONTAINER in 1 CARTON (0113-0734-03) > 27 LOZENGE in 1 CONTAINER4 container2013-04-220000-00-00NoNoCurrent
0113-0734-04001130734045 CONTAINER in 1 CARTON (0113-0734-04) / 27 LOZENGE in 1 CONTAINER (0113-0734-01) 5 container2024-06-21NoNoHistorical
0113-0734-07001130734078 CONTAINER in 1 CARTON (0113-0734-07) / 27 LOZENGE in 1 CONTAINER (0113-0734-01) 8 container2024-06-21NoNoHistorical
0113-0734-60001130734601 CONTAINER in 1 CARTON (0113-0734-60) / 20 LOZENGE in 1 CONTAINER1 container2018-03-260000-00-00NoNoCurrent