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Itch Relief

Kroger 295.000/295AA-AB Itch Relief Spray

Approved
Approval ID

106a2968-444a-e77d-e063-6394a90aa8c3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Mar 31, 2025

Manufacturers
FDA

The Kroger Co

DUNS: 006999528

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diphenhydramine HCl, Zinc acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59450-295
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl, Zinc acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 31, 2025
FDA Product Classification

INGREDIENTS (7)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ZINC ACETATEActive
Quantity: 1 mg in 1 mL
Code: FM5526K07A
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: TC2D6JAD40
Classification: ACTIB
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Itch Relief - FDA Drug Approval Details