FDA.reportPublic FDA data

Nicotine

Product NDC
11822-0456
11-digit product format
118220456
Labeler code
11822
Product ID
11822-0456_5c28282d-c850-46e8-96c7-e7b44881a8d5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA076777
Marketing category
ANDA
Marketing start
2006-10-26
Marketing end
2027-01-31
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0456-1Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0456-1Nicotine100 in 1 CARTONGUM, CHEWING1008
11822-0456-2Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0456-2Nicotine40 in 1 CARTONGUM, CHEWING408
11822-0456-3Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0456-3Nicotine160 in 1 CARTONGUM, CHEWING1608
11822-0456-4Nicotine1 in 1 BLISTER PACKGUM, CHEWING18
11822-0456-4Nicotine120 in 1 CARTONGUM, CHEWING1208

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
GELATININACTIVE INGREDIENT2G86QN327LNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0456NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]7Current NDC, Legacy NDC, 8 package rows20250305_b5d5bdb5-8961-4c8a-9f58-4f23044264a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNb5d5bdb5-8961-4c8a-9f58-4f23044264a68
314119nicotine 2 MG Chewing GumSCDb5d5bdb5-8961-4c8a-9f58-4f23044264a68
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYb5d5bdb5-8961-4c8a-9f58-4f23044264a68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0456-111822045601100 BLISTER PACK in 1 CARTON (11822-0456-1) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2006-10-262027-01-31NoNoCurrent
11822-0456-2118220456021 in 1 BLISTER PACKHistorical
11822-0456-3118220456031 in 1 BLISTER PACKHistorical
11822-0456-4118220456041 in 1 BLISTER PACKHistorical