FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-0344
11-digit product format
001130344
Labeler code
0113
Product ID
0113-0344_425412f0-cd0b-4f06-b76c-99d525e613a5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-07-25
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
0113-0344-03Good Sense Nicotine24 in 1 CONTAINERLOZENGE246
0113-0344-05Good Sense Nicotine3 in 1 CARTONLOZENGE36
0113-0344-05Good Sense Nicotine24 in 1 CONTAINERLOZENGE246
0113-0344-06Good Sense Nicotine4 in 1 CARTONLOZENGE46
0113-0344-06Good Sense Nicotine24 in 1 CONTAINERLOZENGE246
0113-0344-09Good Sense Nicotine27 in 1 CONTAINERLOZENGE276
0113-0344-14Good Sense Nicotine8 in 1 CARTONLOZENGE86
0113-0344-16Good Sense Nicotine6 in 1 CARTONLOZENGE66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0344-05EA - Each0113-0344423381e8-6594-4512-9989-c68f50622d5412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
NICOTINEACTIVE MOIETY6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]3
NICOTINEACTIVE INGREDIENT6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
NICOTINEACTIVE MOIETY6M3C89ZY6RGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEGOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0344GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]6Current NDC, Legacy NDC, 8 package rows20240622_c505dde1-2647-4c7b-99f5-9865e7c78e43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359817nicotine 2 MG Oral LozengePSNc505dde1-2647-4c7b-99f5-9865e7c78e436
359817nicotine 2 MG Oral LozengeSCDc505dde1-2647-4c7b-99f5-9865e7c78e436
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYc505dde1-2647-4c7b-99f5-9865e7c78e436
359817nicotine 2 MG TrocheSYc505dde1-2647-4c7b-99f5-9865e7c78e436
359817nicotine 2 MG Oral LozengePSN4bb7687d-3ee0-47a3-aa43-146dede4cf551
359817nicotine 2 MG Oral LozengePSNd84f27e4-c63b-4d04-9e65-bdb1a3594f921
359817nicotine 2 MG Oral LozengeSCD4bb7687d-3ee0-47a3-aa43-146dede4cf551
359817nicotine 2 MG Oral LozengeSCDd84f27e4-c63b-4d04-9e65-bdb1a3594f921
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY4bb7687d-3ee0-47a3-aa43-146dede4cf551
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSYd84f27e4-c63b-4d04-9e65-bdb1a3594f921
359817nicotine 2 MG TrocheSY4bb7687d-3ee0-47a3-aa43-146dede4cf551
359817nicotine 2 MG TrocheSYd84f27e4-c63b-4d04-9e65-bdb1a3594f921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0344-030011303440324 in 1 CONTAINERHistorical
0113-0344-05001130344053 CONTAINER in 1 CARTON (0113-0344-05) / 24 LOZENGE in 1 CONTAINER3 container2009-11-280000-00-00NoNoCurrent
0113-0344-06001130344064 CONTAINER in 1 CARTON (0113-0344-06) > 24 LOZENGE in 1 CONTAINER4 container2017-01-170000-00-00NoNoCurrent
0113-0344-090011303440927 in 1 CONTAINERHistorical
0113-0344-14001130344148 CONTAINER in 1 CARTON (0113-0344-14) / 27 LOZENGE in 1 CONTAINER (0113-0344-09) 8 container2024-06-18NoNoHistorical
0113-0344-16001130344166 CONTAINER in 1 CARTON (0113-0344-16) / 24 LOZENGE in 1 CONTAINER (0113-0344-03) 6 container2024-06-18NoNoHistorical