Home NDC 68788-8078-2 hydrocortisone
Product NDC 68788-8078
Requested package NDC 68788-8078-2
11-digit product format 687888078
Labeler code 68788
Product ID 68788-8078_be97b8ac-56c7-456f-b7b3-17c89a82a503
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Preferred Pharmaceuticals Inc.
Application part348
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-03
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 106258 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 68788-8078-2 hydrocortisone 1 in 1 CARTON CREAM 1 6 68788-8078-2 hydrocortisone 28 g in 1 TUBE CREAM 28 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8078 HYDROCORTISONE CREAM [PREFERRED PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240522_12cd35e3-e707-4551-b778-bf615c1a8d32.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 Marketing end Sample Exclude flag Status 68788-8078-2 68788807802 1 TUBE in 1 CARTON (68788-8078-2) / 28 g in 1 TUBE 1 tube 2021-09-03 0000-00-00 No No Current