Home NDC 69367-397-01 Lidocaine Hydrochloride and Hydrocortisone Acetate
Product NDC 69367-397
Requested package NDC 69367-397-01
11-digit product format 693670397
Labeler code 69367
Product ID 69367-397_7cb595ac-4371-425c-9da9-c26a9d9ec9a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride and Hydrocortisone Acetate
Dosage form CREAM
Route TOPICAL
Labeler Westminster Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-11-15
Substance HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength 5; 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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Lidocaine Hydrochloride and Hydrocortisone Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 5 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 1012235 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 69367-397-01 Lidocaine Hydrochloride and Hydrocortisone Acetate 1 in 1 CARTON CREAM 1 3 69367-397-01 Lidocaine Hydrochloride and Hydrocortisone Acetate 28.35 g in 1 TUBE CREAM 28.35 3 69367-397-85 Lidocaine Hydrochloride and Hydrocortisone Acetate 1 in 1 CARTON CREAM 1 3 69367-397-85 Lidocaine Hydrochloride and Hydrocortisone Acetate 85 g in 1 TUBE CREAM 85 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-397 LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE CREAM [WESTMINSTER PHARMACEUTICALS, LLC] 1 Current NDC, 4 package rows 20241122_0cd1394d-e7b2-4e60-87ac-e12a0bda9d67.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 69367-397-01 69367039701 1 TUBE in 1 CARTON (69367-397-01) / 28.35 g in 1 TUBE 1 tube 2024-11-15 No No Current