NDC 28595-225 - Hydrocortisone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
28595-225
Package NDCs from labels
28595-225-31
Manufacturer
Allegis Pharmaceuicals LLC
Effective date
2025-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Lotion Kit - Allegis Pharmaceuicals LLCAllegis Pharmaceuicals LLC2025-01-08HUMAN PRESCRIPTION DRUG LABEL
Hydrocortisone Lotion Kit - Scite PharmaScite Pharma2024-01-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28595-225HYDROCORT (HYDROCORTISONE LOTION KIT) KIT [SCITE PHARMA]2Unmatched20240120_fd8a0661-a0a7-892b-e053-6394a90af82d.zip
28595-225HYDROCORTISONE (HYDROCORTISONE LOTION KIT) KIT [ALLEGIS PHARMACEUICALS LLC]2Unmatched20250110_026b8919-31f8-e708-e063-6394a90ad401.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 142 of 142 · 2,822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sit CleanBENZALKONIUM CHLORIDESit Cleanef2b12f8-89b3-47c4-88bd-8712a84cfc452016-08-18WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.