Home NDC 55550-521 Be Smart Get Prepared Burn Cream
Product NDC 55550-521
11-digit product format 555500521
Labeler code 55550
Product ID 55550-521_19ae996c-122d-43ef-8068-a257ad604f75
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride, Lidocaine Hydrochloride Anhydrous
Dosage form CREAM
Route TOPICAL
Labeler Total Resources International, Inc
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-16
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength .13; .5 g/100g; g/100g
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 Be Smart Get Prepared Burn Cream
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100g LIDOCAINE HYDROCHLORIDE ANHYDROUS .5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup EC2CNF7XFP 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 55550-521-01 Be Smart Get Prepared Burn Cream 0.9 g in 1 POUCH CREAM 0.9 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55550-521 BE SMART GET PREPARED BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS) CREAM [TOTAL RESOURCES INTERNATIONAL, INC] 1 Current NDC, 1 package rows 20240823_eacb5138-4af8-4550-b883-5603ad96ed7d.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 Marketing start Sample Exclude flag Status 55550-521-01 55550052101 .9 g in 1 POUCH (55550-521-01) 2024-08-16 No No Current