Home NDC 58980-824 Lidocaine
Product NDC 58980-824
11-digit product format 589800824
Labeler code 58980
Product ID 58980-824_6d26e7b3-bcd8-46de-9ae1-6010b4014fc1
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form CREAM
Route TOPICAL
Labeler Stratus Pharmaceuticals Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-15
Substance LIDOCAINE
Active strength 40 mg/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [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 Lidocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1421893 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58980-824 LIDOCAINE CREAM [STRATUS PHARMACEUTICALS INC] 2 Current NDC, 6 package rows 20240922_e1a8d4a7-01f7-4bab-8d09-875c461b3b61.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 73 of 152 · 3,029 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 58980-824-05 58980082405 1 TUBE in 1 BOX (58980-824-05) / 14.17 g in 1 TUBE 1 tube 2024-09-20 No No Current 58980-824-15 58980082415 5 TUBE in 1 BOX, UNIT-DOSE (58980-824-15) / 5 g in 1 TUBE 5 tube 2024-09-20 No No Current 58980-824-30 58980082430 1 TUBE in 1 BOX (58980-824-30) / 28.35 g in 1 TUBE 1 tube 2024-02-15 No No Current