Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
GCP Laboratories
965480861
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GCP Laboratories
Geri-Care Pharmaceuticals, Corp
GCP Laboratories
965480861
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
KO-LANTA
Product Details
NDC Product Code
57896-004Application Number
M001Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
March 31, 2025BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDInactive
Code: T4V6TWG28DClass: IACT
DimethiconeActive
Code: 92RU3N3Y1OClass: ACTIBQuantity: 20 mg in 5 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2Class: IACT
Aluminum hydroxideActive
Code: 5QB0T2IUN0Class: ACTIBQuantity: 200 mg in 5 mL
Magnesium hydroxideActive
Code: NBZ3QY004SClass: ACTIBQuantity: 200 mg in 5 mL