FDA.reportPublic FDA data

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 96 of 142 · 2,833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact identifier
unii: WI4X0X7BPJ
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
unii: F5UM2KM3W7
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
unii: WI4X0X7BPJ
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc00179db3-5a76-4724-a848-28e71eb580a62025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial 2XBENZALKONIUM CHLORIDESante Manufacturing Inc3e65e67d-c7d0-2fcb-e054-00144ff8d46c2025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Aqua Clear 2X UltraBENZALKONIUM CHLORIDESante Manufacturing Incd5d15729-1dc1-2b44-e053-2a95a90a26c52025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Sipa hand sanitizer S.pray with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbc3c5d-c231-9024-e053-6294a90a9c592025-01-07WarningsExact identifier
unii: F5UM2KM3W7
Ormadus Foodservice Antibacterial FoamBENZALKONIUM CHLORIDESC Johnson Professional USA Inc71cd4be3-1cdf-4e49-be7b-405fe12288d22025-01-07WarningsExact identifier
unii: F5UM2KM3W7
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial BathingBENZALKONIUM CHLORIDECardinal Health, Inc.586463f3-d117-47ae-bbab-f7caff1f5fa82025-01-06WarningsExact identifier
unii: F5UM2KM3W7
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
unii: F5UM2KM3W7
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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