Home NDC 13925-164 Lidocaine Hydrochloride and Hydrocortisone Acetate
Product NDC 13925-164
11-digit product format 139250164
Labeler code 13925
Product ID 13925-164_465d3f2b-451a-43eb-83d2-f36ed3bba282
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride and Hydrocortisone Acetate
Dosage form GEL
Route RECTAL
Labeler Seton Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-06-17
Substance HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength 25; 30 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 Additional Listing Data#
Finished product Yes
Brand name base Lidocaine Hydrochloride and Hydrocortisone Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 25 mg/g HYDROCORTISONE ACETATE 30 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 1012223 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 13925-164-07 Lidocaine Hydrochloride and Hydrocortisone Acetate 7 g in 1 TUBE GEL 7 5 13925-164-20 Lidocaine Hydrochloride and Hydrocortisone Acetate 20 in 1 KIT GEL 20 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13925-164 LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE GEL [SETON PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20240131_fd6343a9-15a6-4894-b51f-122e4d6dbe79.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 13925-164-07 13925016407 7 g in 1 TUBE 7 g Historical 13925-164-20 13925016420 20 TUBE in 1 KIT (13925-164-20) / 7 g in 1 TUBE (13925-164-07) 20 tube 2011-06-17 0000-00-00 No No Current