Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
DLC Laboratories, Inc.
093351930
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colirio Ocusan
Product Details
NDC Product Code
24286-1575Application Number
M018Marketing Category
OTC Monograph Drug (C200263)Route of Administration
OPHTHALMICEffective Date
April 18, 2025BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QOClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Polyethylene glycol 400Active
Code: B697894SGQClass: ACTIBQuantity: 10 mg in 1 mL
PovidoneActive
Code: FZ989GH94EClass: ACTIBQuantity: 10 mg in 1 mL
DextranActive
Code: 7SA290YK68Class: ACTIBQuantity: 1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
TetryzolineActive
Code: 0YZT43HS7DClass: ACTIBQuantity: 0.5 mg in 1 mL
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.