Home NDC 59088-817-01 Lidocaine HCl - Hydrocortisone Acetate
Product NDC 59088-817
Requested package NDC 59088-817-01
11-digit product format 590880817
Labeler code 59088
Product ID 59088-817_2b4af474-aece-35c6-e063-6294a90ae7dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine HCl and Hydrocortisone Acetate
Dosage form GEL
Route RECTAL
Labeler PureTek Corporation
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-07-01
Substance HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength 5.5; 28 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 59088-817 59088-817-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 59088-817 59088-817-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Lidocaine HCl - Hydrocortisone Acetate
Brand name suffix with Aloe
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 5.5 mg/g HYDROCORTISONE ACETATE 28 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 1012221 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 59088-817-01 Lidocaine HCl - Hydrocortisone Acetatewith Aloe 1 in 1 KIT GEL 1 3 59088-817-07 Lidocaine HCl - Hydrocortisone Acetatewith Aloe 100 g in 1 TUBE GEL 100 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59088-817 LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION] 3 Current NDC, Legacy NDC, 2 package rows 20250131_454b8854-44d9-4cdb-a2e4-a782e36bed80.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 Marketing end Sample Exclude flag Status 59088-817-01 59088081701 1 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) 1 tube 2011-07-01 2026-12-31 No No Current