Nicotine

Product NDC
30142-859
11-digit product format
301420859
Labeler code
30142
Product ID
30142-859_7b37f038-65cd-4c84-ae4f-6bee26aab6d1
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
The Kroger Co.
Application
ANDA074507
Marketing category
ANDA
Marketing start
2022-06-03
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
30142-859_7b37f038-65cd-4c84-ae4f-6bee26aab6d1
SPL ID
7b37f038-65cd-4c84-ae4f-6bee26aab6d1
Product type
HUMAN OTC DRUG
Finished product
Yes
Brand name base
Nicotine
Generic name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Marketing start
2022-06-03
Marketing category
ANDA
Application number
ANDA074507
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC]; Nicotine [CS]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
NICOTINE2 mg/1

openFDA Harmonized Identifiers

FieldValues
Unii6M3C89ZY6R
Rxcui314119
Spl Set Id8c81c885-1d56-4dca-b9bc-adfc9bf58051
Manufacturer NameThe Kroger Co.

openFDA Package Details

Package NDCDescriptionMarketing startSample
30142-859-11110 BLISTER PACK in 1 CARTON (30142-859-11) / 1 GUM, CHEWING in 1 BLISTER PACK2022-06-03No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6M3C89ZY6RNICOTINE54-11-5NICOTINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
30142-859-1130142085911110 BLISTER PACK in 1 CARTON (30142-859-11) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2022-06-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsThe Kroger Co.2025-02-25HUMAN OTC DRUG LABEL3