Home NDC 59088-328-03 Hydroxate Gel
Product NDC 59088-328
Requested package NDC 59088-328-03
11-digit product format 590880328
Labeler code 59088
Product ID 59088-328_13bc5f75-b5ca-4d48-e063-6394a90ab608
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE 2%
Dosage form GEL
Route TOPICAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-03-15
Substance HYDROCORTISONE
Active strength 20 mg/g
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 Hydroxate Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 20 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 604449 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 59088-328-03 Hydroxate Gel 28 g in 1 TUBE GEL 28 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-328 HYDROXATE GEL (HYDROCORTISONE 2%) GEL [PURETEK CORPORATION] 1 Current NDC, 1 package rows 20240317_13bc5f75-b5cb-4d48-e063-6394a90ab608.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 1 of 1 · 1 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 59088-328-03 59088032803 28 g in 1 TUBE (59088-328-03) 28 g 2024-03-15 No No Current