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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0363-0025
Application NumberM008
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bismuth subsalicylate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
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