FDA.reportPublic FDA data

Nicotine Transdermal Patches

Manufacturer
Good Manager Holdings Inc
Effective date
2021-11-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:44:57

Label at a glance#

ProductNicotine Transdermal Patches
Active ingredientNICOTINE, MENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC-KEEP OUT OF REACH OF CHILDREN SECTIONOTC-KEEP OUT OF REACH OF CHILDREN SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

OTC-PURPOSE SECTIONOTC-PURPOSE SECTION

WARNINGS SECTION

WARNINGS SECTIONWARNINGS SECTION

OTC - WHEN USING SECTION

OTC-WHEN USING SECTIONOTC-WHEN USING SECTION

OTC - ASK DOCTOR SECTION

OTC-ASK DOCTOR SECTIONOTC-ASK DOCTOR SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTION

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

ROUTE METHOD FREQUENCY OF ADMINISTRATIONROUTE METHOD FREQUENCY OF ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage administration sectionDosage administration section

INDICATIONS & USAGE SECTION

Indications usage sectionIndications usage section

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal PatchesNicotine Transdermal Patches

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82372-001-002023-01-30C16284748780-1f386c649-cc79-0266-e053-dadaa90a7c1ad0f883e5-b02c-cb8a-e053-2a95a90a90c1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82372-001-00Nicotine Transdermal Patches21 in 1 BOXPATCH214
82372-001-00Nicotine Transdermal Patches21 mg in 1 PATCHPATCH214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82372-001NICOTINE TRANSDERMAL PATCHES (DAVV NICOTINE TRANSDERMAL PATCHES - STOP SMOKING AID) PATCH [GOOD MANAGER HOLDINGS INC]4Legacy NDC, 2 package rows20211118_d0f883e5-b02c-cb8a-e053-2a95a90a90c1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82372-00182372-001-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
NICOTINE6M3C89ZY6RACTIB
MENTHOLL7T10EIP3AACTIB
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT

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
d0f883e5-b02d-cb8a-e053-2a95a90a90c1d0f883e5-b02c-cb8a-e053-2a95a90a90c12021-11-17WarningsExact identifier
spl id: d0f883e5-b02d-cb8a-e053-2a95a90a90c1
spl set id: d0f883e5-b02c-cb8a-e053-2a95a90a90c1

Reported adverse events (FAERS/openFDA)#

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