Home NDC 0404-0166 Hydrocortisone
Product NDC 0404-0166
11-digit product format 004040166
Labeler code 0404
Product ID 0404-0166_5d41f237-8bd9-334d-e063-6294a90a8da3
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Henry Schein
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-07
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
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-0166-50 Hydrocortisone 1 in 1 BOX CREAM 1 4 0404-0166-50 Hydrocortisone 72 in 1 CASE CREAM 72 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-0166 HYDROCORTISONE CREAM [HENRY SCHEIN] 3 Current NDC, Legacy NDC, 2 package rows 20241129_eb031535-d17e-9d5e-e053-2a95a90ad3e0.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 0404-0166-50 00404016650 72 BOX in 1 CASE (0404-0166-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE 72 box 2022-11-07 0000-00-00 No No Current