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
NDC Product Code55505-197
Application NumberM008
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateApril 17, 2025
Generic NameBismuth subsalicylate
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