Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
JEFFERS
094385218
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
COSCO INTERNATIONAL, INC.
JEFFERS
JEFFERS
016433141
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
JEFFERS ANTI-ITCH EAR DROPS
Product Details
NDC Product Code
86010-200Route of Administration
AURICULAR (OTIC)Effective Date
February 21, 2025PHENCARBAMIDEInactive
Code: 59H17J9F1BClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Polysorbate 20Inactive
Code: 7T1F30V5YHClass: IACT
HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 10 g in 1000 g
POTASSIUM IODIDEInactive
Code: 1C4QK22F9JClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT