Home NDC 51672-2018 Hydrocortisone
Product NDC 51672-2018
11-digit product format 516722018
Labeler code 51672
Product ID 51672-2018_36204f5e-ffd4-0b6c-e063-6394a90a2098
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-10-03
Substance HYDROCORTISONE
Active strength 1 g/100g
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 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 203105 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 51672-2018-2 Hydrocortisone 28.4 g in 1 TUBE OINTMENT 28.4 4 51672-2018-2 Hydrocortisone 1 in 1 CARTON OINTMENT 1 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2018 HYDROCORTISONE OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250529_f7aecfb4-c194-4554-8d05-4e46005e654b.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 8 of 156 · 3,115 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 51672-2018-2 51672201802 1 TUBE in 1 CARTON (51672-2018-2) / 28.4 g in 1 TUBE 1 tube 1989-10-03 0000-00-00 No No Current