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 21 of 143 · 2,849 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
berkley jensenBENZALKONIUM CHLORIDEApollo Health and Beauty Careda94f82d-42aa-41e8-e053-2995a90a83812026-05-08WarningsExact identifier
unii: F5UM2KM3W7
berkley jensenBENZALKONIUM CHLORIDEApollo Health and Beauty Careda96ccad-bf6d-7634-e053-2995a90abc472026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify Clean and Protect Cool Splash LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d8b8a8-9d15-ad76-e063-6294a90a05212026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBWENZALKONIUM CHLORIDEApollo Health and Beauty Care42f5125b-3b72-4154-e063-6394a90a83c32026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Hyvee Foaming LHS-PearBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f55d37-c234-acaa-e063-6394a90ae4532026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Discount Drug MartBENZALKONIUM CHLORIDEApollo Health and Beauty Care46b44696-8a1a-9ecf-e063-6394a90a42532026-05-08WarningsExact identifier
unii: F5UM2KM3W7
White TeaBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f48f5b-40eb-ca73-e063-6294a90ae84a2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Lightning X Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.5136065e-8dc9-0dae-e063-6294a90a3f9d2026-05-07WarningsExact identifier
unii: ND2M416302
AntibacterialBENZALKONIUM CHLORIDESante Manufacturing Inc3e52df25-deca-07d1-e054-00144ff88e882026-05-07WarningsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDESante Manufcaturing Inc3e5c5148-3196-2899-e054-00144ff8d46c2026-05-07WarningsExact identifier
unii: F5UM2KM3W7
Harris Teeter HydrocortisoneHYDROCORTISONEHARRIS TEETER LLC4e8199f8-96ec-5342-e063-6294a90afb2d2026-05-07WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Inc.5114cdba-96a1-c399-e063-6294a90aac122026-05-06WarningsExact identifier
unii: WI4X0X7BPJ
Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEAmbition Power Brands5132bc70-bf3b-180c-e063-6394a90afdad2026-05-06WarningsExact identifier
unii: F5UM2KM3W7
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
caring mill Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.80997bb6-b878-45d4-a6e9-4ae37442d67e2026-05-06WarningsExact identifier
unii: ND2M416302
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
HandsoapBENZALKONIUM CHLORIDETopco Associates LLCe60ff14a-f78d-c9fa-e053-2995a90a7f102026-05-05WarningsExact identifier
unii: F5UM2KM3W7
Kroger Springwater AntibacterialBENZALKONIUM CHLORIDEKroger Company01006967-d11c-d02a-e063-6394a90ad42c2026-05-04WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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