Nicotine
Rite Aid Corporation Nicotine Gum Drug Facts
Approved
Approval ID
e808dd98-3307-4dcf-b042-910ea6c3170a
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 25, 2025
Manufacturers
FDA
Rite Aid Corporation
DUNS: 014578892
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 Code11822-0029
Application NumberANDA076775
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nicotine Polacrilex
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2025
FDA Product Classification
INGREDIENTS (9)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
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