Kaopectate Vanilla Flavor Anti Diarrheal
Drug Facts
Approved
Approval ID
3ad310c8-3dfa-4435-87bf-17f1c0a9ca45
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 Code55505-198
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 (8)
Bismuth SubsalicylateActive
Quantity: 262 mg in 15 mL
Code: 62TEY51RR1
Classification: ACTIB
Carboxymethylcellulose Sodium, UnspecifiedInactive
Code: K679OBS311
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Sodium SalicylateInactive
Code: WIQ1H85SYP
Classification: IACT
Sorbic AcidInactive
Code: X045WJ989B
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Xanthan GumInactive
Code: TTV12P4NEE
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/15/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 11/15/2023
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/7/2022
WARNINGS SECTION
LOINC: 34071-1Updated: 11/15/2023
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 11/15/2023
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 11/15/2023
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 11/15/2023