Home NDC 11527-052 Dr. Sheffield Hydrocortisone Anti itch
Product NDC 11527-052
11-digit product format 115270052
Labeler code 11527
Product ID 11527-052_73503439-5ce2-480b-bf3f-9362a31c8e29
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Sheffield Pharmaceuticals LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-07-10
Substance HYDROCORTISONE
Active strength 10 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 Dr. Sheffield Hydrocortisone Anti itch
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 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 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 11527-052-51 Dr. Sheffield Hydrocortisone Anti itch 1 in 1 CARTON CREAM 1 4 11527-052-51 Dr. Sheffield Hydrocortisone Anti itch 14 g in 1 TUBE CREAM 14 4 11527-052-55 Dr. Sheffield Hydrocortisone Anti itch 1 in 1 CARTON CREAM 1 4 11527-052-55 Dr. Sheffield Hydrocortisone Anti itch 28 g in 1 TUBE CREAM 28 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-052 DR. SHEFFIELD HYDROCORTISONE ANTI ITCH (HYDROCORTISONE) CREAM [SHEFFIELD PHARMACEUTICALS LLC] 4 Current NDC, Legacy NDC, 4 package rows 20231031_71c9f2f4-2188-45eb-b55e-3856ac78070b.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 18 of 153 · 3,057 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 11527-052-51 11527005251 1 TUBE in 1 CARTON (11527-052-51) / 14 g in 1 TUBE 1 tube 2007-07-10 0000-00-00 No No Current 11527-052-55 11527005255 1 TUBE in 1 CARTON (11527-052-55) / 28 g in 1 TUBE 1 tube 2007-07-10 0000-00-00 No No Current