Home NDC 58228-2045 Hydrocortisone 1%
Product NDC 58228-2045
11-digit product format 582282045
Labeler code 58228
Product ID 58228-2045_46013b99-8359-912c-e063-6294a90a1050
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone 1%
Dosage form CREAM
Route TOPICAL
Labeler ProStat First Aid LLC
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-10
Substance HYDROCORTISONE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone 1%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58228-2045-1 Hydrocortisone 1% 0.9 g in 1 PACKET CREAM 0.9 3 58228-2045-1 Hydrocortisone 1% 25 in 1 BOX CREAM 25 3 58228-2045-2 Hydrocortisone 1% 1800 in 1 CASE CREAM 1800 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58228-2045 HYDROCORTISONE 1% CREAM [PROSTAT FIRST AID LLC] 2 Current NDC, 3 package rows 20241127_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 16 of 31 · 615 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58228-2045-1 58228204501 0.9 g in 1 PACKET 0.9 g Historical 58228-2045-2 58228204502 1800 BOX in 1 CASE (58228-2045-2) / 25 PACKET in 1 BOX (58228-2045-1) / .9 g in 1 PACKET 1800 box 2023-04-10 No No Current