FDA.reportPublic FDA data

nicotine

Product NDC
30142-848
11-digit product format
301420848
Labeler code
30142
Product ID
30142-848_3a2d524e-c6fc-4084-ba29-a6f5991b66ea
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Kroger Company
Application
ANDA206393
Marketing category
ANDA
Marketing start
2019-06-05
Substance
NICOTINE
Active strength
4 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
nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-848-06nicotine1 in 1 BLISTER PACKGUM, CHEWING15
30142-848-06nicotine160 in 1 CARTONGUM, CHEWING1605
30142-848-60nicotine1 in 1 BLISTER PACKGUM, CHEWING15
30142-848-60nicotine20 in 1 CARTONGUM, CHEWING205
30142-848-76nicotine1 in 1 BLISTER PACKGUM, CHEWING15
30142-848-76nicotine120 in 1 CARTONGUM, CHEWING1205
30142-848-78nicotine100 in 1 CARTONGUM, CHEWING1005
30142-848-78nicotine1 in 1 BLISTER PACKGUM, CHEWING15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-848NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [KROGER COMPANY]5Current NDC, Legacy NDC, 8 package rows20250308_37ad9304-7a00-4ec0-bbbb-cf133e0e8bc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSN37ad9304-7a00-4ec0-bbbb-cf133e0e8bc85
311975nicotine 4 MG Chewing GumSCD37ad9304-7a00-4ec0-bbbb-cf133e0e8bc85
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY37ad9304-7a00-4ec0-bbbb-cf133e0e8bc85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-848-0630142084806160 BLISTER PACK in 1 CARTON (30142-848-06) / 1 GUM, CHEWING in 1 BLISTER PACK160 blister pack2019-06-110000-00-00NoNoCurrent
30142-848-603014208486020 BLISTER PACK in 1 CARTON (30142-848-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2019-06-110000-00-00NoNoCurrent
30142-848-7630142084876120 BLISTER PACK in 1 CARTON (30142-848-76) > 1 GUM, CHEWING in 1 BLISTER PACK120 blister pack2019-06-110000-00-00NoNoCurrent
30142-848-7830142084878100 BLISTER PACK in 1 CARTON (30142-848-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2019-06-050000-00-00NoNoCurrent