Home NDC 87525-003 FifthPulse Hydrocortisone
Product NDC 87525-003
11-digit product format 875250003
Labeler code 87525
Product ID 87525-003_4e7d1d38-aabe-62ac-e063-6394a90ac753
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form OINTMENT
Route TOPICAL
Labeler WeCare Products LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-30
Substance HYDROCORTISONE
Active strength 10 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 FifthPulse Hydrocortisone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/g
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 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 87525-003-01 FifthPulse Hydrocortisone 1 in 1 BOX OINTMENT 1 1 87525-003-01 FifthPulse Hydrocortisone 28.4 g in 1 TUBE OINTMENT 28.4 1 87525-003-02 FifthPulse Hydrocortisone 113.4 g in 1 TUBE OINTMENT 113.4 1 87525-003-02 FifthPulse Hydrocortisone 1 in 1 BOX OINTMENT 1 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87525-003-01 87525000301 1 TUBE in 1 BOX (87525-003-01) / 28.4 g in 1 TUBE 1 tube 2026-04-30 No No Current 87525-003-02 87525000302 1 TUBE in 1 BOX (87525-003-02) / 113.4 g in 1 TUBE 1 tube 2026-04-30 No No Current