Home NDC 43473-040 FIRSTAR BURN
Product NDC 43473-040
11-digit product format 434730040
Labeler code 43473
Product ID 43473-040_510a2766-13a9-97a7-e063-6294a90aeba4
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form CREAM
Route TOPICAL
Labeler Nantong Health & Beyond Hygienic Products Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-02
Substance LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength .5; .13 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 FIRSTAR BURN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE .5 g/100g BENZALKONIUM CHLORIDE .13 g/100g
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 43473-040-01 FIRSTAR BURN 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 43473-040 FIRSTAR BURN (LIDOCAINE HYDROCHLORIDE) CREAM [NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC.] 2 Current NDC, 1 package rows 20240704_186343c5-2e71-49c4-8d64-5fb3131239fa.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 Marketing start Sample Exclude flag Status 43473-040-01 43473004001 .9 g in 1 PACKET (43473-040-01) 2024-07-02 No No Current