NICOTINE

Product NDC
42507-343
11-digit product format
425070343
Labeler code
42507
Product ID
42507-343_ea59f977-2b62-4c7b-9735-99c8fd2f4ffe
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
HyVee Inc
Application
ANDA206394
Marketing category
ANDA
Marketing start
2026-02-25
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6M3C89ZY6RNICOTINE54-11-5NICOTINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-343-7842507034378100 BLISTER PACK in 1 CARTON (42507-343-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2026-02-25NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hy-Vee, Inc. Nicotine Drug FactsHyVee Inc2026-03-11HUMAN OTC DRUG LABEL2