FDA.reportPublic FDA data

Nicorette

Product NDC
0135-0241
11-digit product format
001350241
Labeler code
0135
Product ID
0135-0241_1e6cbf12-d37d-1a4b-e063-6394a90ade6a
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA018612
Marketing category
NDA
Marketing start
2009-09-14
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
Nicorette
Brand name suffix
Fruit Chill
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui105071, 209326, 311975, 314119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0241-022024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-032024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-052024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-062024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-082024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-112024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-142024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-152024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-172024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-182024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts
0135-0241-192024-01-30C16284748780-11030e364-fdd8-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0241-02NicoretteFruit Chill100 in 1 BLISTER PACKGUM, CHEWING10020
0135-0241-02NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0241-03NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0241-03NicoretteFruit Chill190 in 1 BLISTER PACKGUM, CHEWING19020
0135-0241-05NicoretteFruit Chill160 in 1 BLISTER PACKGUM, CHEWING16020
0135-0241-05NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0241-06NicoretteFruit Chill20 in 1 BLISTER PACKGUM, CHEWING2020
0135-0241-06NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0241-08NicoretteFruit Chill20 in 1 CARTONGUM, CHEWING2020
0135-0241-11NicoretteFruit Chill10 in 1 BLISTER PACKGUM, CHEWING1020
0135-0241-11NicoretteFruit Chill1 in 1 CARTONGUM, CHEWING120
0135-0241-14NicoretteFruit Chill25 in 1 CARTONGUM, CHEWING2520
0135-0241-15NicoretteFruit Chill25 in 1 CARTONGUM, CHEWING2520
0135-0241-15NicoretteFruit Chill8 in 1 PACKAGEGUM, CHEWING820
0135-0241-17NicoretteFruit Chill10 in 1 CARTONGUM, CHEWING1020
0135-0241-17NicoretteFruit Chill2 in 1 PACKAGEGUM, CHEWING220
0135-0241-18NicoretteFruit Chill12 in 1 CARTONGUM, CHEWING1220
0135-0241-18NicoretteFruit Chill10 in 1 BLISTER PACKGUM, CHEWING1020
0135-0241-19NicoretteFruit Chill18 in 1 CARTONGUM, CHEWING1820
0135-0241-19NicoretteFruit Chill10 in 1 BLISTER PACKGUM, CHEWING1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0241-02EA - Each0135-02412111fe2e-defe-4d1d-80d4-c240edcb337612012-07-24
0135-0241-03EA - Each0135-0241e736941f-ecbb-4fa4-ab01-f3418a7ca31812015-10-02
0135-0241-05EA - Each0135-0241dbe01191-e0e8-40ee-928e-5476206cc20d12014-02-04
0135-0241-06EA - Each0135-0241d443bfb1-cb27-459c-97e6-7a06ba28084412012-07-24
0135-0241-08EA - Each0135-0241b81b5537-8010-4f37-8c8c-9aab803f7e3d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
NICOTINEACTIVE MOIETY6M3C89ZY6RNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACACIAINACTIVE INGREDIENT5C5403N26ONICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0241NICORETTE FRUIT CHILL (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 20 package rows20240731_a0206139-59c6-44c3-963c-8cb5f2d69075.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209326Nicorette 2 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
105071Nicorette 4 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
314119nicotine polacrilex 2 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
311975nicotine polacrilex 4 MG Chewing GumPSNa0206139-59c6-44c3-963c-8cb5f2d6907520
209326nicotine 2 MG Chewing Gum [Nicorette]SBDa0206139-59c6-44c3-963c-8cb5f2d6907520
105071nicotine 4 MG Chewing Gum [Nicorette]SBDa0206139-59c6-44c3-963c-8cb5f2d6907520
314119nicotine 2 MG Chewing GumSCDa0206139-59c6-44c3-963c-8cb5f2d6907520
311975nicotine 4 MG Chewing GumSCDa0206139-59c6-44c3-963c-8cb5f2d6907520
209326Nicorette 2 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
209326Nicorette 2 MG Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
105071Nicorette 4 MG Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYa0206139-59c6-44c3-963c-8cb5f2d6907520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0241-02001350241021 BLISTER PACK in 1 CARTON (0135-0241-02) / 100 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-09-140000-00-00NoNoCurrent
0135-0241-03001350241031 in 1 CARTONHistorical
0135-0241-05001350241051 BLISTER PACK in 1 CARTON (0135-0241-05) / 160 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-09-140000-00-00NoNoCurrent
0135-0241-06001350241061 BLISTER PACK in 1 CARTON (0135-0241-06) / 20 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-09-140000-00-00NoNoCurrent
0135-0241-080013502410820 GUM, CHEWING in 1 CARTON (0135-0241-08) 2009-09-140000-00-00NoNoCurrent
0135-0241-110013502411110 in 1 BLISTER PACKHistorical
0135-0241-140013502411425 in 1 CARTONHistorical
0135-0241-150013502411525 in 1 CARTONHistorical
0135-0241-17001350241172 CARTON in 1 PACKAGE (0135-0241-17) / 10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK2 carton2014-08-010000-00-00NoNoCurrent
0135-0241-180013502411812 BLISTER PACK in 1 CARTON (0135-0241-18) / 10 GUM, CHEWING in 1 BLISTER PACK12 blister pack2018-09-010000-00-00NoNoCurrent
0135-0241-190013502411918 BLISTER PACK in 1 CARTON (0135-0241-19) / 10 GUM, CHEWING in 1 BLISTER PACK18 blister pack2018-12-030000-00-00NoNoCurrent