FDA.reportPublic FDA data

Nicorette

Product NDC
0135-0229
11-digit product format
001350229
Labeler code
0135
Product ID
0135-0229_1f929250-cbfa-d6eb-e063-6394a90a7281
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
2009-06-29
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
Mint
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
0135-0229-032024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0229-042024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts
0135-0229-052024-01-30C16284748780-19d75b9d0-509e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0229-03NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0229-03NicoretteMint50 in 1 BLISTER PACKGUM, CHEWING5027
0135-0229-04NicoretteMint110 in 1 BLISTER PACKGUM, CHEWING11027
0135-0229-04NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0229-05NicoretteMint1 in 1 CARTONGUM, CHEWING127
0135-0229-05NicoretteMint170 in 1 BLISTER PACKGUM, CHEWING17027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0229-05EA - Each0135-022905397702-6ffe-449a-b0af-4e4d7c2fe5e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
NICOTINEACTIVE MOIETY6M3C89ZY6RNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
ACACIAINACTIVE INGREDIENT5C5403N26ONICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
LEVOMENTHOLINACTIVE INGREDIENTBZ1R15MTK7NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SORBITOLINACTIVE INGREDIENT506T60A25RNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1NNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE FRESH MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0229NICORETTE WHITE ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE CINNAMON SURGE (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE MINT (NICOTINE POLACRILEX) GUM, CHEWING NICORETTE SPEARMINT BURST (NICOTINE POLACRILEX) GUM, CHEWING [HALEON US HOLDINGS LLC]27Current NDC, Legacy NDC, 6 package rows20240815_673fd19f-69b3-4f73-b9b4-18b5f4cbf69c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209326Nicorette 2 MG Chewing GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
105071Nicorette 4 MG Chewing GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
314119nicotine polacrilex 2 MG Chewing GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
311975nicotine polacrilex 4 MG Chewing GumPSN673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
209326nicotine 2 MG Chewing Gum [Nicorette]SBD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
105071nicotine 4 MG Chewing Gum [Nicorette]SBD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
314119nicotine 2 MG Chewing GumSCD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
311975nicotine 4 MG Chewing GumSCD673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
209326Nicorette 2 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
209326Nicorette 2 MG Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
105071Nicorette 4 MG Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY673fd19f-69b3-4f73-b9b4-18b5f4cbf69c27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0229-03001350229031 in 1 CARTONHistorical
0135-0229-0400135022904110 in 1 BLISTER PACKHistorical
0135-0229-05001350229051 BLISTER PACK in 1 CARTON (0135-0229-05) / 170 GUM, CHEWING in 1 BLISTER PACK1 blister pack2009-06-290000-00-00NoNoCurrent