FDA.reportPublic FDA data

NICORETTE

Product NDC
0135-0511
11-digit product format
001350511
Labeler code
0135
Product ID
0135-0511_142b2250-8264-423f-e063-6394a90ab05b
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA021330
Marketing category
NDA
Marketing start
2010-10-19
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
NICORETTE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui359817, 359818, 968849, 968851

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0511-012020-11-16C16284748780-19d75b9d0-7564-f424-e053-dadaa90a57ceDrug Facts
0135-0511-062020-11-16C16284748780-19d75b9d0-7564-f424-e053-dadaa90a57ceDrug Facts
0135-0511-072020-11-16C16284748780-19d75b9d0-7564-f424-e053-dadaa90a57ceDrug Facts
0135-0511-012020-01-31C16284748780-19d75b9d0-7564-f424-e053-dadaa90a57ceDrug Facts
0135-0511-062020-01-31C16284748780-19d75b9d0-7564-f424-e053-dadaa90a57ceDrug Facts
0135-0511-072020-01-31C16284748780-19d75b9d0-7564-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0511-01NICORETTE3 in 1 CARTONLOZENGE320
0135-0511-01NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0511-06NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0511-06NICORETTE1 in 1 CARTONLOZENGE120
0135-0511-07NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0511-07NICORETTE6 in 1 CARTONLOZENGE620

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0511-01EA - Each0135-0511a15c6572-22c0-4827-ab60-2544221fea9112012-07-24
0135-0511-02EA - Each0135-051119849702-0312-4cf2-b678-b2a3fc06e30912012-07-24
0135-0511-05EA - Each0135-051140820f4d-e6eb-4d21-bf3a-9ad2abdee4a312012-07-24
0135-0511-06EA - Each0135-051171f603e6-7317-4301-8d67-4ad8760fa06712016-06-14
0135-0511-07EA - Each0135-0511bfceb1a7-9df3-4cd3-bce1-1221e7ab2a0812016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
NICOTINEACTIVE MOIETY6M3C89ZY6RNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACACIAINACTIVE INGREDIENT5C5403N26ONICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
EUGENOLINACTIVE INGREDIENT3T8H1794QWNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
PALM KERNEL OILINACTIVE INGREDIENTB0S90M0233NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SOY PROTEININACTIVE INGREDIENTR44IWB3RN5NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0511NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 6 package rows20240322_991704ed-781a-489b-8b56-0b558e8fc385.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
968849Nicorette 2 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
968851Nicorette 4 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG Oral LozengePSN991704ed-781a-489b-8b56-0b558e8fc38520
968849nicotine 2 MG Oral Lozenge [Nicorette]SBD991704ed-781a-489b-8b56-0b558e8fc38520
968851nicotine 4 MG Oral Lozenge [Nicorette]SBD991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG Oral LozengeSCD991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG Oral LozengeSCD991704ed-781a-489b-8b56-0b558e8fc38520
968849Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
968849Nicorette 2 MG Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
968849Nicorette 2 MG TrocheSY991704ed-781a-489b-8b56-0b558e8fc38520
968851Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
968851Nicorette 4 MG Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
359817nicotine 2 MG TrocheSY991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY991704ed-781a-489b-8b56-0b558e8fc38520
359818nicotine 4 MG TrocheSY991704ed-781a-489b-8b56-0b558e8fc38520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0511-01001350511013 CONTAINER in 1 CARTON (0135-0511-01) / 24 LOZENGE in 1 CONTAINER3 container2010-10-190000-00-00NoNoCurrent
0135-0511-06001350511061 CONTAINER in 1 CARTON (0135-0511-06) / 24 LOZENGE in 1 CONTAINER1 container2015-09-010000-00-00NoNoCurrent
0135-0511-07001350511076 CONTAINER in 1 CARTON (0135-0511-07) / 24 LOZENGE in 1 CONTAINER6 container2015-09-010000-00-00NoNoCurrent