Nicotine

Product NDC
72224-930
11-digit product format
722240930
Labeler code
72224
Product ID
72224-930_8891aa24-6b1a-45ca-8004-5d4e18b8a03d
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Lucy Goods, Inc.
Application
ANDA079219
Marketing category
ANDA
Marketing start
2025-04-25
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
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
72224-930-10Nicotine100 in 1 CARTONGUM, CHEWING1002
72224-930-10Nicotine1 in 1 BLISTER PACKGUM, CHEWING12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72224-930NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [LUCY GOODS, INC.]1Current NDC, 2 package rows20250427_bca1c2ab-2263-429d-9f09-f848dd3d826e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNbca1c2ab-2263-429d-9f09-f848dd3d826e2
311975nicotine 4 MG Chewing GumSCDbca1c2ab-2263-429d-9f09-f848dd3d826e2
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYbca1c2ab-2263-429d-9f09-f848dd3d826e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72224-930-1072224093010100 BLISTER PACK in 1 CARTON (72224-930-10) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2025-04-25NoNoCurrent