FDA.reportPublic FDA data

quit smoking patches

Product NDC
87135-001
Requested package NDC
87135-001-01
11-digit product format
871350001
Labeler code
87135
Product ID
87135-001_40b1c2ab-a14e-0884-e063-6294a90a6ecb
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
PATCH
Route
TOPICAL
Labeler
Henan Jiugao Cross-border Ecommerce Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-09
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
quit smoking patches
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
40b1c2ab-a14d-0884-e063-6294a90a6ecbAvailable 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
87135-001-01quit smoking patches30 in 1 BOXPATCH301
87135-001-01quit smoking 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
quit smoking patchesNICOTINEHenan Jiugao Cross-border Ecommerce Co., Ltd.40b1c2ab-a14d-0884-e063-6294a90a6ecb2025-10-08WarningsExact identifier
ndc (package): 87135-001-01
ndc (product): 87135-001
ndc11 (package): 87135000101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN40b1c2ab-a14d-0884-e063-6294a90a6ecb1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD40b1c2ab-a14d-0884-e063-6294a90a6ecb1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY40b1c2ab-a14d-0884-e063-6294a90a6ecb1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY40b1c2ab-a14d-0884-e063-6294a90a6ecb1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY40b1c2ab-a14d-0884-e063-6294a90a6ecb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87135-001-018713500010130 PATCH in 1 BOX (87135-001-01) / 1 PATCH in 1 PATCH30 patch2025-10-09NoNoCurrent