Home NDC 36800-031 Lidocaine
Product NDC 36800-031
11-digit product format 368000031
Labeler code 36800
Product ID 36800-031_5c2c2b25-a945-dbab-e063-6394a90aff0f
Type HUMAN OTC DRUG
Nonproprietary name Burn Relief
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Topco Associates LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-01-03
Substance LIDOCAINE
Active strength .64 g/127g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE .64 g/127g
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-031-45 Lidocaine 127 g in 1 CAN AEROSOL, SPRAY 127 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-031 LIDOCAINE (BURN RELIEF) AEROSOL, SPRAY [TOPCO ASSOCIATES LLC] 11 Current NDC, Legacy NDC, 1 package rows 20241213_5faa1d39-12ce-4a65-8e53-0c040e914540.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 18 of 153 · 3,057 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 36800-031-45 36800003145 127 g in 1 CAN (36800-031-45) 127 g 2012-01-03 0000-00-00 No No Current