Kaopectate
Drug Facts
Approved
Approval ID
3877a88d-9546-48ce-ad6b-3c2a115e3eaf
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 Code55505-197
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 (14)
Bismuth SubsalicylateActive
Quantity: 262 mg in 1 1
Code: 62TEY51RR1
Classification: ACTIB
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Hydrated SilicaInactive
Code: Y6O7T4G8P9
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/30/2020
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 10/1/2020
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 9/28/2020
WARNINGS SECTION
LOINC: 34071-1Updated: 10/1/2020
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 9/28/2020
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/28/2020
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 9/28/2020