Home NDC 59088-317 Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream
Product NDC 59088-317
11-digit product format 590880317
Labeler code 59088
Product ID 59088-317_1a01b416-2ca4-c7fa-e063-6394a90a341b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine HCl, Hydrocortisone Acetate
Dosage form CREAM
Route TOPICAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-06-03
Substance LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE
Active strength 38.8; 10 mg/g; mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]
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 Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 38.8 mg/g HYDROCORTISONE ACETATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup 3X7931PO74 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2683735 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 59088-317-07 Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream 85 g in 1 TUBE CREAM 85 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-317 LIDOTRAL 3.88 PERCENT PLUS HYDROCORTISONE 1 PERCENT CREAM (LIDOCAINE HCL, HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION] 1 Current NDC, 1 package rows 20240605_1a01b416-2ca5-c7fa-e063-6394a90a341b.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 Sample Exclude flag Status 59088-317-07 59088031707 85 g in 1 TUBE (59088-317-07) 85 g 2024-06-03 No No Current