Home NDC 56104-250 Hydrocortisone
Product NDC 56104-250
11-digit product format 561040250
Labeler code 56104
Product ID 56104-250_422b3418-94ea-ea94-e063-6294a90ac334
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Continuous Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Premier Brands of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-20
Substance HYDROCORTISONE
Active strength 1.13 g/113g
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1.13 g/113g
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 317564 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 56104-250-00 Hydrocortisone 113 g in 1 CAN AEROSOL, SPRAY 113 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56104-250 HYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241017_d344f68b-9b62-3029-e053-2995a90a1665.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 56104-250-00 56104025000 113 g in 1 CAN (56104-250-00) 113 g 2021-12-20 0000-00-00 No No Current