FDA.reportPublic FDA data

Nicotine

Product NDC
0363-0456
11-digit product format
003630456
Labeler code
0363
Product ID
0363-0456_12951177-c09c-4254-a0fe-9ef2c90056ce
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreen Company
Application
ANDA076777
Marketing category
ANDA
Marketing start
2006-10-27
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Listing expiration
2027-12-31

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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0456-06Nicotine1 in 1 BLISTER PACKGUM, CHEWING19
0363-0456-06Nicotine160 in 1 CARTONGUM, CHEWING1609
0363-0456-58Nicotine1 in 1 BLISTER PACKGUM, CHEWING19
0363-0456-58Nicotine40 in 1 CARTONGUM, CHEWING409
0363-0456-60Nicotine20 in 1 CARTONGUM, CHEWING209
0363-0456-60Nicotine1 in 1 BLISTER PACKGUM, CHEWING19
0363-0456-76Nicotine120 in 1 CARTONGUM, CHEWING1209
0363-0456-76Nicotine1 in 1 BLISTER PACKGUM, CHEWING19
0363-0456-78Nicotine100 in 1 CARTONGUM, CHEWING1009
0363-0456-78Nicotine1 in 1 BLISTER PACKGUM, CHEWING19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0456-06EA - Each0363-0456d78a5e62-08b1-4dc0-bacb-71443f69b6ba12022-06-06
0363-0456-58EA - Each0363-0456a4e15ca1-a941-447a-96e2-8f0dd8f8c3c812013-10-17
0363-0456-60EA - Each0363-0456fc3f1caa-e514-466e-bd7b-12d4ddca42fe12014-07-02
0363-0456-78EA - Each0363-0456c141f769-d428-452b-9ad1-073c710c0e1e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
GELATININACTIVE INGREDIENT2G86QN327LNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QONICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
SORBITOLINACTIVE INGREDIENT506T60A25RNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ENICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0456NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]8Current NDC, Legacy NDC, 10 package rows20240716_dc1ffb6b-0865-4854-bbbd-97606995e3f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNdc1ffb6b-0865-4854-bbbd-97606995e3f49
314119nicotine 2 MG Chewing GumSCDdc1ffb6b-0865-4854-bbbd-97606995e3f49
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYdc1ffb6b-0865-4854-bbbd-97606995e3f49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0456-0600363045606160 BLISTER PACK in 1 CARTON (0363-0456-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2007-02-220000-00-00NoNoCurrent
0363-0456-58003630456581 in 1 BLISTER PACKHistorical
0363-0456-600036304566020 BLISTER PACK in 1 CARTON (0363-0456-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2013-09-270000-00-00NoNoCurrent
0363-0456-7600363045676120 BLISTER PACK in 1 CARTON (0363-0456-76) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2014-03-230000-00-00NoNoCurrent
0363-0456-7800363045678100 BLISTER PACK in 1 CARTON (0363-0456-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2006-10-270000-00-00NoNoCurrent