NICOTINE

Product NDC
21130-636
11-digit product format
211300636
Labeler code
21130
Product ID
21130-636_461718e6-2a05-44b5-b6b0-509f2064c3aa
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
LOZENGE
Route
ORAL
Labeler
Safeway
Application
ANDA077007
Marketing category
ANDA
Marketing start
2025-09-15
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6M3C89ZY6RNICOTINE54-11-5NICOTINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-636-05211300636051 BOTTLE in 1 CARTON (21130-636-05) / 72 LOZENGE in 1 BOTTLE (21130-636-03) 1 bottle2025-09-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Better Living Brands LLC Nicotine Lozenge Drug FactsSafeway2025-10-08HUMAN OTC DRUG LABEL2