STPSMK QUIT SMOKING NICOTINE PATCHES

Product NDC
87231-001
Requested package NDC
87231-001-02
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
STPSMK QUIT SMOKING NICOTINE PATCHES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE28 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2707585Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43c1b4e9-39ee-d398-e063-6394a90a71f0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87231-001-01STPSMK QUIT SMOKING NICOTINE PATCHES1 in 1 PATCHPATCH11
87231-001-01STPSMK QUIT SMOKING NICOTINE PATCHES15 in 1 BOXPATCH151
87231-001-02STPSMK QUIT SMOKING NICOTINE PATCHES30 in 1 BOXPATCH301
87231-001-02STPSMK QUIT SMOKING NICOTINE PATCHES1 in 1 PATCHPATCH11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STPSMK QUIT SMOKING NICOTINE PATCHESNICOTINEGuangzhou Ouruisi Biotechnology Co., Ltd43c1b4e9-39ee-d398-e063-6394a90a71f02025-11-16WarningsExact identifier
ndc (package): 87231-001-02
ndc (product): 87231-001
ndc11 (package): 87231000102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2707585nicotine 28 MG/Day 24HR Transdermal PatchPSN43c1b4e9-39ee-d398-e063-6394a90a71f01
270758524 HR nicotine 1.17 MG/HR Transdermal SystemSCD43c1b4e9-39ee-d398-e063-6394a90a71f01
2707585nicotine 28 MG/Day 24 HR Transdermal PatchSY43c1b4e9-39ee-d398-e063-6394a90a71f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87231-001-028723100010230 PATCH in 1 BOX (87231-001-02) / 1 PATCH in 1 PATCH30 patch2025-11-17NoNoCurrent