Nicotine Patches

Manufacturer
Zhejiang FTA Shengzuozhi Biotechnology Co., LTD
Effective date
2025-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:48

Label at a glance#

ProductNicotine Patches
Active ingredientNICOTINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid

Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

WARNINGS SECTION

keep out of reach of children section.

OTC - PURPOSE SECTION

·apply one new patch every 24 hours on skin that is dry, clean and hairless

·remove backing from patch and immediately press onto skin. Hold for 10 seconds.

·wash hands after applying or removing patch. Save pouch to use for patch disposal.

·the used patch should be removed and a new one applied to a different skin site at the same time each day.

·Dispose of the patches carefully after you have removed ensuring they are out of the reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children section

DOSAGE & ADMINISTRATION SECTION

Nicotine 42mg delivered over 24 hours.......................................................Stop Smoking aid

Nicotine 21mg delivered over 24 hours.......................................................Stop Smoking aid

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

INDICATIONS & USAGE SECTION

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

INACTIVE INGREDIENT SECTION

Nicotine 42mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
85333-002-01Nicotine Patches42 mg in 1 PATCHPATCH421
85333-002-02Nicotine Patches14 in 1 BOXPATCH141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85333-002NICOTINE PATCHES PATCH [ZHEJIANG FTA SHENGZUOZHI BIOTECHNOLOGY CO., LTD]1Current NDC, 2 package rows20250327_313b08e2-d764-96da-e063-6294a90ab705.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85333-00285333-002-01, 85333-002-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
NICOTINE6M3C89ZY6RACTIB

Source Document#

Source XML

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 PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD313b08e2-d764-96da-e063-6294a90ab7052025-03-25WarningsExact identifier
ndc (package): 85333-002-01
ndc (package): 85333-002-02
ndc (product): 85333-002
ndc11 (package): 85333000201
ndc11 (package): 85333000202
spl id: 313b0492-51e6-bf6d-e063-6394a90a3a05
spl set id: 313b08e2-d764-96da-e063-6294a90ab705

Reported adverse events (FAERS/openFDA)#

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