Home NDC 51672-5335 Hydrocortisone
Product NDC 51672-5335
11-digit product format 516725335
Labeler code 51672
Product ID 51672-5335_5933787d-8cc1-5959-e063-6394a90a9f80
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Cream 1/2%
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-31
Substance HYDROCORTISONE
Active strength .5 g/100g
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 Hydrocortisone
Brand name suffix with Aloe
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE .5 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 198707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 108 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51672-5335-2 51672533502 1 TUBE in 1 CARTON (51672-5335-2) / 28.4 g in 1 TUBE 1 tube 2026-07-31 No No Current