signature care nicotine
Better Living Brands LLC Nicotine Gum Drug Facts
Approved
Approval ID
a2c00ec8-3762-4594-a1dd-0b5add001d39
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 27, 2025
Manufacturers
FDA
Safeway
DUNS: 009137209
Products 1
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 Code21130-269
Application NumberANDA206394
Product Classification
M
Marketing Category
C73584
G
Generic Name
nicotine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 27, 2025
FDA Product Classification
INGREDIENTS (15)
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
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT