Home NDC 45802-276 hydrocortisone
Product NDC 45802-276
11-digit product format 458020276
Labeler code 45802
Product ID 45802-276_cf5167f6-cf70-463f-baf8-70fd83a993ff
Type HUMAN OTC DRUG
Nonproprietary name hydrocortisone
Dosage form OINTMENT
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-08-18
Substance HYDROCORTISONE
Active strength 1 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
Listing expiration 2027-12-31 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 45802-276-03 hydrocortisone 1 in 1 CARTON OINTMENT 1 7 45802-276-03 hydrocortisone 28 g in 1 TUBE OINTMENT 28 7
DailyMed Socrata Ingredients# 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 45802-276-03 45802027603 1 TUBE in 1 CARTON (45802-276-03) / 28 g in 1 TUBE 1 tube 2011-08-18 0000-00-00 No No Current