Good Sense Nicotine
Perrigo Nicotine Polacrilex Gum 2 mg (nicotine) Drug Facts
Approved
Approval ID
7744ea8b-164a-4992-9874-a2b59bee585d
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 21, 2025
Manufacturers
FDA
L. Perrigo Company
DUNS: 006013346
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 Code0113-0029
Application NumberANDA076775
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2025
FDA Product Classification
INGREDIENTS (9)
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
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT