Home NDC 69168-488 Carbamide peroxide 6.5%
Product NDC 69168-488
11-digit product format 691680488
Labeler code 69168
Product ID 69168-488_4f1c9234-6bb1-4795-af84-731f628424db
Type HUMAN OTC DRUG
Nonproprietary name Earwax Removal Kit
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler Allegiant Health
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-28
Substance CARBAMIDE PEROXIDE
Active strength 65 mg/mL
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 Carbamide peroxide 6.5%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMIDE PEROXIDE 65 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 31PZ2VAU81 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 702050 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 69168-488-68 Carbamide peroxide 6.5% 1 in 1 CARTON SOLUTION/ DROPS 1 2 69168-488-68 Carbamide peroxide 6.5% 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 2
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 4 of 7 · 135 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 69168-488-68 69168048868 1 BOTTLE, DROPPER in 1 CARTON (69168-488-68) / 15 mL in 1 BOTTLE, DROPPER 2025-10-28 No No Current