FDA.reportPublic FDA data

Nicotine Stop Smoking AID

Product NDC
87278-002
11-digit product format
872780002
Labeler code
87278
Product ID
87278-002_45a7e1cf-7183-6ec3-e063-6394a90ae441
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Guangxi Keyun E-commerce Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-11
Substance
NICOTINE
Active strength
21 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Stop Smoking AID
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 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
198030Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45a7e1cf-7182-6ec3-e063-6394a90ae441Available 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
87278-002-01Nicotine Stop Smoking AID1 in 1 PATCHPATCH11
87278-002-01Nicotine Stop Smoking AID60 in 1 BOXPATCH601

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
Nicotine Stop Smoking AIDNICOTINEGuangxi Keyun E-commerce Co., Ltd.45a7e1cf-7182-6ec3-e063-6394a90ae4412025-12-11WarningsExact identifier
ndc (product): 87278-002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN45a7e1cf-7182-6ec3-e063-6394a90ae4411
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD45a7e1cf-7182-6ec3-e063-6394a90ae4411
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY45a7e1cf-7182-6ec3-e063-6394a90ae4411
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY45a7e1cf-7182-6ec3-e063-6394a90ae4411
198030nicotine 21 MG/Day 24HR Transdermal SystemSY45a7e1cf-7182-6ec3-e063-6394a90ae4411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87278-002-018727800020160 PATCH in 1 BOX (87278-002-01) / 1 PATCH in 1 PATCH60 patch2025-12-11NoNoCurrent