Home NDC 81522-914 Hydrocortisone
Product NDC 81522-914
11-digit product format 815220914
Labeler code 81522
Product ID 81522-914_3ce24e45-ca33-d85d-e063-6294a90af326
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Spray
Dosage form SPRAY
Route TOPICAL
Labeler FSA Store Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-19
Substance HYDROCORTISONE
Active strength 10 mg/mL
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 10 mg/mL
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 81522-914-01 Hydrocortisone 74 mL in 1 BOTTLE, SPRAY SPRAY 74 1
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 Sample Exclude flag Status 81522-914-01 81522091401 74 mL in 1 BOTTLE, SPRAY (81522-914-01) 74 ml 2025-08-19 No No Current