Soothe
Drug Facts
Approved
Approval ID
82f2b3a4-3428-4046-9372-2ef9046a071c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Walgreens
DUNS: 008965063
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Bismuth subsalicylate
PRODUCT DETAILS
NDC Product Code0363-0025
Application NumberM008
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic NameBismuth subsalicylate
INGREDIENTS (12)
BISMUTH SUBSALICYLATEActive
Quantity: 525 mg in 30 mL
Code: 62TEY51RR1
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
D&C RED NO. 22Inactive
Code: 1678RKX8RT
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
SODIUM SALICYLATEInactive
Code: WIQ1H85SYP
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
METHYLCELLULOSE (1500 CPS)Inactive
Code: P0NTE48364
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT