Home NDC 57896-146 Hydrocortisone 1%
Product NDC 57896-146
11-digit product format 578960146
Labeler code 57896
Product ID 57896-146_297d9001-099e-b15d-e063-6394a90a8aea
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Geri-Care Pharmaceuticals, Corp
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-31
Substance HYDROCORTISONE
Active strength 1 g/100g
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 Hydrocortisone 1%
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 57896-146-14 Hydrocortisone 1% 144 in 1 CARTON CREAM 144 2 57896-146-14 Hydrocortisone 1% 0.9 g in 1 PACKET CREAM 0.9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-146 HYDROCORTISONE 1% (HYDROCORTISONE) CREAM [GERI-CARE PHARMACEUTICALS, CORP] 2 Current NDC, 2 package rows 20241220_fd67566a-1076-019d-e053-6394a90a415c.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 Sample Exclude flag Status 57896-146-14 57896014614 144 PACKET in 1 CARTON (57896-146-14) / .9 g in 1 PACKET 144 packet 2023-05-31 No No Current