Home NDC 51628-0368 American Red Cross First Aid
Product NDC 51628-0368
11-digit product format 516280368
Labeler code 51628
Product ID 51628-0368_34157041-22de-3e61-e063-6394a90aa5c2
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form SPRAY
Route TOPICAL
Labeler MY IMPORTS USA, LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-01
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength 1.3; 40 mg/mL; mg/mL
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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns When using this product do not use in or near the eyes do not apply over large areas of the body or in large quantities do not apply over raw surfaces or blistered areas. Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days, or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base American Red Cross First Aid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL LIDOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii F5UM2KM3W7, V13007Z41A Rxcui 2047877
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51628-0368-0 American Red Cross First Aid 88.72 mL in 1 BOTTLE SPRAY 88.72 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51628-0368 AMERICAN RED CROSS FIRST AID (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) SPRAY [MY IMPORTS USA, LLC] 1 Current NDC, 1 package rows 20250503_667ab8ce-e110-4b7f-a158-3cdd3b7a1c29.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51628-0368-0 51628036800 88.72 mL in 1 BOTTLE (51628-0368-0) 88.72 ml 2025-05-01 No No Current