Nicotine
NICOTINE PATCH Drug Facts
Approved
Approval ID
7c83d507-7e8d-496c-bb9d-63abfa25c7a7
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60429-443
Application NumberNDA020076
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nicotine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (2)
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
NICOTINEActive
Quantity: 7 mg in 24 h
Code: 6M3C89ZY6R
Classification: ACTIB
Nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60429-444
Application NumberNDA020076
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nicotine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (2)
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
NICOTINEActive
Quantity: 14 mg in 24 h
Code: 6M3C89ZY6R
Classification: ACTIB
Nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60429-445
Application NumberNDA020076
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nicotine
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (2)
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
NICOTINEActive
Quantity: 21 mg in 24 h
Code: 6M3C89ZY6R
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 1/21/2016
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 5/14/2015
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 5/14/2015
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 5/14/2015
WARNINGS SECTION
LOINC: 34071-1Updated: 3/25/2019
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 5/14/2015
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 5/14/2015
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 3/16/2016
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 5/14/2015