Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Consumer Product Partners, LLC
119091520
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Consumer Product Partners, LLC
The Kroger Co
Consumer Product Partners, LLC
119091514
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Itch Relief
Product Details
NDC Product Code
59450-295Application Number
M016Marketing Category
OTC Monograph Drug (C200263)Route of Administration
TOPICALEffective Date
March 31, 2025GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
Zinc acetateActive
Code: FM5526K07AClass: ACTIBQuantity: 1 mg in 1 mL
POVIDONEInactive
Code: FZ989GH94EClass: IACT
DiphenhydramineActive
Code: TC2D6JAD40Class: ACTIBQuantity: 20 mg in 1 mL
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT