Kaopectate
Drug Facts
Approved
Approval ID
2f6766a1-d775-40bf-a039-975ab47fcceb
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Kramer Laboratories
DUNS: 122720675
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 Code55505-206
Application NumberM008
Product Classification
M
Marketing Category
C200263
G
Generic Name
Bismuth subsalicylate
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (9)
Bismuth SubsalicylateActive
Quantity: 262 mg in 1 1
Code: 62TEY51RR1
Classification: ACTIB
Calcium CarbonateInactive
Code: H0G9379FGK
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Corn SyrupInactive
Code: 9G5L16BK6N
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Hydrogenated Coconut OilInactive
Code: JY81OXM1OM
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Lecithin, SoybeanInactive
Code: 1DI56QDM62
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/13/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 10/1/2020
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 1/29/2021
WARNINGS SECTION
LOINC: 34071-1Updated: 1/29/2021
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 2/4/2021
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 1/29/2021
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 1/29/2021