Pepto Bismol
Pepto Bismol CHEWABLES
Approved
Approval ID
30b6adb2-48da-875b-e063-6394a90a593b
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 19, 2025
Manufacturers
FDA
Procter & Gamble Manufactura S de RL de CV
DUNS: 812807550
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 Code58933-002
Application NumberM008
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bismuth Subsalicylate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 19, 2025
FDA Product Classification
INGREDIENTS (11)
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
D&C RED NO. 27 ALUMINUM LAKEInactive
Code: ZK64F7XSTX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ADIPIC ACIDInactive
Code: 76A0JE0FKJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
BISMUTH SUBSALICYLATEActive
Quantity: 262 mg in 1 1
Code: 62TEY51RR1
Classification: ACTIB