Home NDC 55621-018 Assured
Product NDC 55621-018
11-digit product format 556210018
Labeler code 55621
Product ID 55621-018_08846c1b-91dd-aadf-e063-6294a90accfa
Type HUMAN OTC DRUG
Nonproprietary name HYDROCORTISONE
Dosage form CREAM
Route TOPICAL
Labeler Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-05-25
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 Assured
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 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 55621-018-28 Assured 28 g in 1 TUBE CREAM 28 6 55621-018-28 Assured 1 in 1 CARTON CREAM 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55621-018 ASSURED (HYDROCORTISONE) CREAM [ZHEJIANG JINGWEI PHARMACEUTIC AL CO., LTD.] 6 Current NDC, Legacy NDC, 2 package rows 20231025_bc97f364-9443-47b8-9c2d-b5dcc00cc9b7.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 152 · 3,029 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 55621-018-28 55621001828 1 TUBE in 1 CARTON (55621-018-28) / 28 g in 1 TUBE 1 tube 2018-05-25 0000-00-00 No No Current