nicotine
Nicotine Polacrilex Gum 2mg Drug Facts
Approved
Approval ID
f9759891-7d3d-4714-8f8b-92d0a499e52e
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 14, 2025
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nicotine polacrilex
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-827
Application NumberANDA206394
Product Classification
M
Marketing Category
C73584
G
Generic Name
nicotine polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2025
FDA Product Classification
INGREDIENTS (12)
NICOTINEActive
Quantity: 2 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
POLACRILINInactive
Code: RCZ785HI7S
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/14/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 6/19/2023
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 6/19/2023
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 6/19/2023
WARNINGS SECTION
LOINC: 34071-1Updated: 6/19/2023
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/14/2025
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 6/19/2023
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 6/19/2023
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 6/19/2023
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/14/2025