FDA.reportPublic FDA data

GUHIO Nicotine Patch

Product NDC
87278-001
Requested package NDC
87278-001-01
11-digit product format
872780001
Labeler code
87278
Product ID
87278-001_45a53cd6-3e40-697a-e063-6394a90a6c83
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

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
GUHIO Nicotine Patch
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
45a53cd6-3e3f-697a-e063-6394a90a6c83Available 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
87278-001-01GUHIO Nicotine Patch42 in 1 BOXPATCH421
87278-001-01GUHIO Nicotine Patch1 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
GUHIO Nicotine PatchNICOTINEGuangxi Keyun E-commerce Co., Ltd.45a53cd6-3e3f-697a-e063-6394a90a6c832025-12-10WarningsExact identifier
ndc (package): 87278-001-01
ndc (product): 87278-001
ndc11 (package): 87278000101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN45a53cd6-3e3f-697a-e063-6394a90a6c831
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD45a53cd6-3e3f-697a-e063-6394a90a6c831
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY45a53cd6-3e3f-697a-e063-6394a90a6c831
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY45a53cd6-3e3f-697a-e063-6394a90a6c831
198030nicotine 21 MG/Day 24HR Transdermal SystemSY45a53cd6-3e3f-697a-e063-6394a90a6c831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87278-001-018727800010142 PATCH in 1 BOX (87278-001-01) / 1 PATCH in 1 PATCH42 patch2025-12-11NoNoCurrent