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 30 of 143 · 2,849 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
unii: WI4X0X7BPJ
SSDC Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.c4063012-34ab-4409-baf4-9e3d8f3e20112026-03-04WarningsExact identifier
unii: F5UM2KM3W7
Isopropyl alcohol 91 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCa6d2068f-705d-4341-b1c8-81e1b563ab9a2026-03-04WarningsExact identifier
unii: ND2M416302
50% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC95e31119-8487-4bc9-b1c2-c43d32fc80ce2026-03-03Warnings, Adverse reactionsExact identifier
unii: ND2M416302
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
unii: WI4X0X7BPJ
SSDC ANTIBACTERIAL FOAM HANDSOAPBENZALKONIUM CHLORIDEEcolab Inc.a2a4e9d1-d63a-476b-a048-d360104e36882026-03-03WarningsExact identifier
unii: F5UM2KM3W7
CortenemaHYDROCORTISONEANI Pharmaceuticals, Inc.a307448a-ccc4-41a8-977a-11f28f0bded92026-03-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
IsopropylISOPROPYL ALCOHOLOld East Main Co.ea6f3065-780e-4afc-a361-a2cb296ae4d52026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Procto-Med HCHYDROCORTISONENuCare Pharmaceuticals,Inc.4b972547-5bd4-155d-e063-6394a90a03ee2026-03-02Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Benzalkonium chlorideBENZALKONIUM CHLORIDEOld East Main Co.4769b25a-1cc5-5d37-e063-6294a90a6fbb2026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDEOld East Main Co.48e813ce-3893-b95f-e063-6294a90a18f22026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEOld East Main Co.29e5da06-8897-4a79-8eea-f359ba0bdf782026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
unii: ND2M416302
AntibacterialBENZALKONIUM CHLORIDEOld East Main Co.3effae93-fd00-4aac-a42f-b5b67123f8512026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Old East Main Co.122154ea-bdb3-4e71-bfd5-f1f28d75fb2e2026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
unii: ND2M416302
HydrocortisoneHYDROCORTISONEANI Pharmaceuticals, Inc.40654d12-56e4-4489-be49-19c60ad918ad2026-03-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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