Home NDC 87541-644 EarBalance Ear Pain Drops
Product NDC 87541-644
11-digit product format 875410644
Labeler code 87541
Product ID 87541-644_573897f4-b336-841b-e063-6394a90a7f99
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine Hydrochloride Otic Solution
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler Marie's Original Formulas LLC
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-15
Substance LIDOCAINE
Active strength 40 mg/mL
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 EarBalance Ear Pain Drops
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 6 of 7 · 135 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87541-644-68 87541064468 14 mL in 1 BOTTLE, PLASTIC (87541-644-68) 14 ml 2026-06-15 No No Current