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
NDC Product Code55505-206
Application NumberM008
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateApril 17, 2025
Generic NameBismuth subsalicylate
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