FDA.reportPublic FDA data

good sense nicotine

Product NDC
0113-0873
11-digit product format
001130873
Labeler code
0113
Product ID
0113-0873_812f7fdb-e2b7-43f3-b24e-36a33eec32d6
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA077007
Marketing category
ANDA
Marketing start
2006-12-27
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
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
0113-0873-03good sense nicotine24 in 1 CONTAINERLOZENGE248
0113-0873-05good sense nicotine3 in 1 CARTONLOZENGE38
0113-0873-06good sense nicotine4 in 1 CARTONLOZENGE48
0113-0873-09good sense nicotine27 in 1 CONTAINERLOZENGE278
0113-0873-14good sense nicotine8 in 1 CARTONLOZENGE88
0113-0873-16good sense nicotine6 in 1 CARTONLOZENGE68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0873-05EA - Each0113-0873b3e2a119-6598-4e26-ae1a-219512a63d9112012-07-24
0113-0873-06EA - Each0113-087378360099-545c-4da9-b8d0-6acd43909b6612018-04-19

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
POLACRILININACTIVE INGREDIENTRCZ785HI7SGOOD 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
0113-0873GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]8Current NDC, Legacy NDC, 6 package rows20240627_ee345181-4999-4948-9589-7d70d61885ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSNee345181-4999-4948-9589-7d70d61885ad8
359818nicotine 4 MG Oral LozengeSCDee345181-4999-4948-9589-7d70d61885ad8
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSYee345181-4999-4948-9589-7d70d61885ad8
359818nicotine 4 MG TrocheSYee345181-4999-4948-9589-7d70d61885ad8
359818nicotine 4 MG Oral LozengePSN3e9a5f94-9db2-4cac-8ab9-50fcedfe0e055
359818nicotine 4 MG Oral LozengeSCD3e9a5f94-9db2-4cac-8ab9-50fcedfe0e055
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY3e9a5f94-9db2-4cac-8ab9-50fcedfe0e055
359818nicotine 4 MG TrocheSY3e9a5f94-9db2-4cac-8ab9-50fcedfe0e055
359818nicotine 4 MG Oral LozengePSN26bfbdad-d67a-41b9-803d-967d438a26721
359818nicotine 4 MG Oral LozengeSCD26bfbdad-d67a-41b9-803d-967d438a26721
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY26bfbdad-d67a-41b9-803d-967d438a26721
359818nicotine 4 MG TrocheSY26bfbdad-d67a-41b9-803d-967d438a26721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0873-030011308730324 in 1 CONTAINERHistorical
0113-0873-05001130873053 CONTAINER in 1 CARTON (0113-0873-05) / 24 LOZENGE in 1 CONTAINER (0113-0873-03) 3 container2009-11-170000-00-00NoNoCurrent
0113-0873-06001130873064 CONTAINER in 1 CARTON (0113-0873-06) > 24 LOZENGE in 1 CONTAINER4 container2017-08-010000-00-00NoNoCurrent
0113-0873-090011308730927 in 1 CONTAINERHistorical
0113-0873-14001130873148 CONTAINER in 1 CARTON (0113-0873-14) / 27 LOZENGE in 1 CONTAINER (0113-0873-09) 8 container2024-06-18NoNoHistorical
0113-0873-16001130873166 CONTAINER in 1 CARTON (0113-0873-16) / 24 LOZENGE in 1 CONTAINER (0113-0873-03) 6 container2024-06-18NoNoHistorical