Nicotine

Product NDC
11822-0854
11-digit product format
118220854
Labeler code
11822
Product ID
11822-0854_1d0e7562-06c6-4623-825f-423e06d6e7aa
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA078546
Marketing category
ANDA
Marketing start
2007-12-21
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNICOTINE (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
11822-0854NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [RITE AID CORPORATION]8Legacy NDC20250331_8837575b-6179-4f92-881b-f19120445ef7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0854-111822085401100 BLISTER PACK in 1 CARTON (11822-0854-1) > 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2007-12-210000-00-00NoNoCurrent
11822-0854-211822085402120 BLISTER PACK in 1 CARTON (11822-0854-2) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2016-10-120000-00-00NoNoCurrent
11822-0854-31182208540310 BLISTER PACK in 1 CARTON (11822-0854-3) > 1 GUM, CHEWING in 1 BLISTER PACK10 blister pack2017-09-200000-00-00NoNoCurrent