STPSMK QUIT SMOKING NICOTINE PATCHES

Product NDC
87231-001
11-digit product format
872310001
Labeler code
87231
Product ID
87231-001_43c1b4e9-39ef-d398-e063-6394a90a71f0
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Guangzhou Ouruisi Biotechnology Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-17
Substance
NICOTINE
Active strength
28 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
87231-001-018723100010115 PATCH in 1 BOX (87231-001-01) / 1 PATCH in 1 PATCH15 patch2025-11-17NoNoHistorical
87231-001-028723100010230 PATCH in 1 BOX (87231-001-02) / 1 PATCH in 1 PATCH30 patch2025-11-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
87231-001 STPSMK QUIT SMOKING NICOTINE PATCHESGuangzhou Ouruisi Biotechnology Co., Ltd2025-11-16HUMAN OTC DRUG LABEL1