FDA.reportPublic FDA data

Good Sense Nicotine

Product NDC
0113-0957
11-digit product format
001130957
Labeler code
0113
Product ID
0113-0957_5a643025-10d5-4251-84bf-9f1c168a8530
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA203690
Marketing category
ANDA
Marketing start
2013-04-27
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
0113-0957-01Good Sense Nicotine27 in 1 CONTAINERLOZENGE278
0113-0957-02Good Sense Nicotine3 in 1 CARTONLOZENGE38
0113-0957-03Good Sense Nicotine27 in 1 CONTAINERLOZENGE278
0113-0957-03Good Sense Nicotine4 in 1 CARTONLOZENGE48
0113-0957-04Good Sense Nicotine5 in 1 CARTONLOZENGE58
0113-0957-07Good Sense Nicotine8 in 1 CARTONLOZENGE88
0113-0957-27Good Sense Nicotine1 in 1 CARTONLOZENGE18
0113-0957-60Good Sense Nicotine20 in 1 CONTAINERLOZENGE208
0113-0957-60Good Sense Nicotine1 in 1 CARTONLOZENGE18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0957-02EA - Each0113-0957faf3bf0f-383b-4f50-9fb1-8cc0b5859d2712017-12-14
0113-0957-60EA - Each0113-0957a80b4478-5d23-4c6b-96cc-659a5425924512021-02-05

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
0113-0957GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [L. PERRIGO COMPANY]6Current NDC, Legacy NDC, 9 package rows20240702_1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359818nicotine 4 MG Oral LozengePSN1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf8
359818nicotine 4 MG Oral LozengeSCD1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf8
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf8
359818nicotine 4 MG TrocheSY1a7cfbdc-53cc-4cd2-86b2-6e27a7979abf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0957-010011309570127 in 1 CONTAINERHistorical
0113-0957-02001130957023 CONTAINER in 1 CARTON (0113-0957-02) / 27 LOZENGE in 1 CONTAINER (0113-0957-01) 3 container2013-04-270000-00-00NoNoCurrent
0113-0957-03001130957034 CONTAINER in 1 CARTON (0113-0957-03) > 27 LOZENGE in 1 CONTAINER4 container2014-09-240000-00-00NoNoCurrent
0113-0957-04001130957045 CONTAINER in 1 CARTON (0113-0957-04) / 27 LOZENGE in 1 CONTAINER (0113-0957-01) 5 container2024-06-21NoNoHistorical
0113-0957-07001130957078 CONTAINER in 1 CARTON (0113-0957-07) / 27 LOZENGE in 1 CONTAINER (0113-0957-01) 8 container2024-06-21NoNoHistorical
0113-0957-27001130957271 CONTAINER in 1 CARTON (0113-0957-27) / 27 LOZENGE in 1 CONTAINER (0113-0957-01) 1 container2026-02-26NoNoHistorical
0113-0957-60001130957601 CONTAINER in 1 CARTON (0113-0957-60) / 20 LOZENGE in 1 CONTAINER1 container2018-03-270000-00-00NoNoCurrent