Home NDC 69396-105 Burn Cream
Product NDC 69396-105
11-digit product format 693960105
Labeler code 69396
Product ID 69396-105_5b10d396-540d-e3b2-e063-6394a90ab26e
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride, Lidocaine HCI
Dosage form CREAM
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-27
Substance LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength .005; .0013 g/g; g/g
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 Burn Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE .005 g/g BENZALKONIUM CHLORIDE .0013 g/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 F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012100 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 69396-105-09 Burn Cream 144 in 1 CARTON CREAM 144 4 69396-105-09 Burn Cream 0.9 g in 1 PACKET CREAM 0.9 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-105 BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICALS USA LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240713_e9a9fc7c-31da-ea3f-e053-2a95a90a0eab.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 9 of 115 · 2,286 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 69396-105-09 69396010509 144 PACKET in 1 CARTON (69396-105-09) / .9 g in 1 PACKET 144 packet 2022-09-27 0000-00-00 No No Current