FDA.reportPublic FDA data

NDC 58228-2045-01 - Hydrocortisone 1%

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
58228-2045
Requested NDC
58228-2045-01
Package NDCs from labels
58228-2045-1, 58228-2045-2, 58228-2045-01
Manufacturer
ProStat First Aid LLC
Effective date
2025-12-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone 1% - ProStat First Aid LLCProStat First Aid LLC2025-12-15HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-2045-1Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.93
58228-2045-1Hydrocortisone 1%25 in 1 BOXCREAM253
58228-2045-2Hydrocortisone 1%1800 in 1 CASECREAM18003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-2045HYDROCORTISONE 1% CREAM [PROSTAT FIRST AID LLC]2Current NDC, 3 package rows20241127_f707bda4-074a-6406-e053-6394a90a7ae1.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 8 of 73 · 1,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zinc Oxide 20%ZINC OXIDE, WHITE PETROLATUMAldermed Inc.54154a72-27ad-7bfa-e063-6394a90a4eca2026-06-12WarningsExact identifier
unii: B6E5W8RQJ4
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
application number: M032
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
rxcui: 106258
unii: WI4X0X7BPJ
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Anti-DandruffZINC PYRITHIONEMEERAY COSMETICS CO., LTD.f5b2d9f2-ff29-2da1-e053-2995a90a68f32026-06-08WarningsExact identifier
application number: M032
Psoriasin Deep MoisturizingCOAL TARKobayashi Healthcare International, Inc.8bb4a84f-dd80-cbbc-e053-2a95a90a04752026-06-08WarningsExact identifier
application number: M032
Head and Shoulders Hutchs Cooling RushPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5383143a-f930-46f8-e063-6294a90a3a752026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Double Coverage 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53835f68-44d8-b1af-e063-6294a90acae92026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Polamalu s Hall of Fame HairPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53839833-d1c2-fa3b-e063-6394a90a6bd92026-06-05WarningsExact identifier
application number: M032
RENUEVO ANTI-DAMDRUFFZINC PYRITHIONELEON UP GLOBAL HOLDING CORP5387b840-ad0a-4c20-e063-6294a90a59e32026-06-05WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Health307e4b16-10ab-44f4-86b9-709d10566d4c2026-06-04WarningsExact identifier
application number: M032
Minoxidil Hair Growth SerumMINOXIDILShenzhen Deshijian Medical Equipment Co., Ltd535cdf78-90bc-86b4-e063-6294a90a2c202026-06-04WarningsExact identifier
application number: M032
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
unii: B6E5W8RQJ4
Dermaharmony Unscented BarSALICYLIC ACIDD3 Development, Inc.52f5885f-2a40-c3f5-e063-6294a90a434e2026-05-29WarningsExact identifier
application number: M032
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsExact identifier
unii: WI4X0X7BPJ
ciprofloxacin hydrochloride and hydrocortisoneCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONESandoz Incc0881bbe-cc95-45d4-9878-3bc8946eff262026-05-29Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Dermoia Psoriasis Treatment Salicylic AcidSALICYLIC ACIDTreasurewise LLCfec62bf1-7423-4806-9ac9-1254d7eb62da2026-05-27WarningsExact identifier
application number: M032
HydrocortisoneHYDROCORTISONEMylan Pharmaceuticals Inc.bc751403-94f2-4f9d-b533-cf6186a40ceb2026-05-25Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
5% Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.5278c9c2-4bce-fed4-e063-6394a90a7f332026-05-23WarningsExact identifier
application number: M032

Reported adverse events (FAERS/openFDA)#

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