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 83 of 143 · 2,849 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Hydrocortisone Intensive Healing FormulaHYDROCORTISONETopco Associates LLC7daafc44-e2a4-4f1b-bfca-3309a8e9a9202025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETARGET Corporation72c3889c-b743-4728-a315-6e4063e002002025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
Shopko Hydrocortisone Maximum StrengthHYDROCORTISONEShopko Stores Operating Co., LLC0431a6af-4c9a-4bbd-a535-cba31a5e53cc2025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
Freds Hydrocortisone with AloeHYDROCORTISONEFRED'S, INC.076503bf-8238-4739-bb1c-c385e72f8a962025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
Shopko HydrocortisoneHYDROCORTISONEShopko Stores Operating Co., LLC92bcbde3-401a-4301-854e-c352852317d62025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
FifthPulse Hydrocortisone 1ozHYDROCORTISONEFront Pharmaceutical PLC39fae2a4-902e-3c88-e063-6394a90acbd52025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
TopCare HydrocortisoneHYDROCORTISONETopco Associates LLCbd3585fa-3b48-49b7-8ad1-749bf1e31ed52025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
FifthPulse Hydrocortisone 4ozHYDROCORTISONEFront Pharmaceutical PLC39fb29c8-6a28-e87e-e063-6294a90a78da2025-07-15WarningsExact identifier
unii: WI4X0X7BPJ
Smart Care ANTIBACTERIAL HAND SANITIZING WIPES FRESH SCENTBENZALKONIUM CHLORIDEAshtel Studios, Inc.a805781b-c28e-4559-9b83-ea39dc51a03b2025-07-15WarningsExact identifier
unii: F5UM2KM3W7
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 461225539cbe8-1d0f-41f8-9c5d-a9af7f28eed12025-07-15WarningsExact identifier
unii: ND2M416302
Equate Hydrocortisone Intensive Healing FormulaHYDROCORTISONEWal-Mart Stores Inc.635b49c4-54d2-4b6d-bee8-851fc2c7ca9c2025-07-14WarningsExact identifier
unii: WI4X0X7BPJ
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 70000bf355e30-ad2f-4f93-9d77-8efd6a908e582025-07-11WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70 Percent WintergreenISOPROPYL ALCOHOLBest Choice (Valu Merchandisers Company)abcc7941-e521-4ad6-89df-0b965b634eb32025-07-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 700005ffa8ecf-1349-4758-8d47-e9a96d2ddaee2025-07-11WarningsExact identifier
unii: ND2M416302
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39904847-ed55-f4a3-e063-6294a90a85a12025-07-10WarningsExact identifier
unii: F5UM2KM3W7
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.397a897a-baab-d209-e063-6294a90aac652025-07-10WarningsExact identifier
unii: F5UM2KM3W7
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.398fd961-d5e6-9d40-e063-6294a90a5be52025-07-10WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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