FDA.reportPublic FDA data

nicotine

Product NDC
0363-1012
11-digit product format
003631012
Labeler code
0363
Product ID
0363-1012_f0cba5af-3e27-4aa0-ba5d-d2db526e4d3f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Walgreen Company
Application
ANDA206394
Marketing category
ANDA
Marketing start
2018-02-02
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
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
0363-1012-06nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-1012-06nicotine160 in 1 CARTONGUM, CHEWING1606
0363-1012-76nicotine120 in 1 CARTONGUM, CHEWING1206
0363-1012-76nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-1012-78nicotine1 in 1 BLISTER PACKGUM, CHEWING16
0363-1012-78nicotine100 in 1 CARTONGUM, CHEWING1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1012NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [WALGREEN COMPANY]5Current NDC, Legacy NDC, 6 package rows20250427_a1258f0a-24d2-40b0-8f44-06f2cafd7d26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNa1258f0a-24d2-40b0-8f44-06f2cafd7d266
314119nicotine 2 MG Chewing GumSCDa1258f0a-24d2-40b0-8f44-06f2cafd7d266
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYa1258f0a-24d2-40b0-8f44-06f2cafd7d266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1012-0600363101206160 BLISTER PACK in 1 CARTON (0363-1012-06) > 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2018-02-050000-00-00NoNoCurrent
0363-1012-7600363101276120 BLISTER PACK in 1 CARTON (0363-1012-76) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2018-02-050000-00-00NoNoCurrent
0363-1012-7800363101278100 BLISTER PACK in 1 CARTON (0363-1012-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2018-02-020000-00-00NoNoCurrent