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 5 of 7 · 135 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ear Wax Removal Drops Up and Up CARBAMIDE PEROXIDE - 6.5% Target Corporation 829ece50-1f26-4f69-b000-010a34d4cd54 2024-11-21 Warnings Exact identifier application number: M014 Walgreens Ear Wax Remover CARBAMIDE PEROXIDE 6.5% Walgreens Company d3b7362b-2826-4b86-bfa3-ef302dc79143 2024-11-20 Warnings Exact identifier application number: M014 CLEARCANAL EAR WAX SOFTERNER DROPS CARBAMIDE PEROXIDE A-S Medication Solutions ac3d57a4-08d5-45f1-be84-f68eef9d1398 2024-11-04 Warnings Exact identifier application number: M014 Caladryl Clear PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE Bausch Health US, LLC fca6f08b-7fa0-4ae6-bce3-61f3bcae4332 2024-10-17 Warnings Exact identifier application number: M014 Caladryl FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE Bausch Health US, LLC 67d4fd42-9fed-4238-9f5a-c9403abbcf20 2024-10-17 Warnings Exact identifier application number: M014 TheraSeal DIMETHICONE Bausch Health US, LLC 2c8dc616-20c1-4d33-8a89-9bcdb22b35c8 2024-10-17 Warnings Exact identifier application number: M014 fungoid tincture MICONAZOLE NITRATE Pedinol Pharmacal, Inc. 250d0a66-01d1-4aba-8f24-4cb4ca529fda 2024-10-17 Warnings Exact identifier application number: M014 GenRx Anti-Bacterial Gel ALCOHOL PureTek Corporation a124e37e-1a44-212a-e053-2995a90a0af0 2024-10-01 Warnings Exact identifier application number: M014 Hand Sanitizing with Lavender Oil ALCOHOL PureTek Corporation a75d25a7-1e23-717f-e053-2a95a90a6d93 2024-10-01 Warnings Exact identifier application number: M014 Leader Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Cardinal Health, Inc. 0022a174-8377-44af-84a9-31adb27de131 2024-08-23 Warnings Exact identifier application number: M014 Leader Earwax Removal Kit Earwax Removal Aid and Bulb CARBAMIDE PEROXIDE Cardinal Health 110 DBA Leader 36c1408b-4287-4e9f-aa17-4f05add50038 2024-08-12 Warnings Exact identifier application number: M014 Major Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Major Pharmaceuticals 513bf82e-a36f-49d0-ba74-c834fea4f3b5 2024-08-12 Warnings Exact identifier application number: M014 Alcohol Wipes WIPE EM ALCOHOL WIPES Shaoxing Elite Bio-Tech Co., Ltd. 1f373096-d3d5-af7f-e063-6394a90a3b55 2024-08-08 Warnings Exact identifier application number: M014 Benzoyl Peroxide Acne Medication BENZOYL PEROXIDE NuCare Pharmaceuticals,Inc. b55acec6-5a4d-08b7-e053-2995a90a0f74 2024-07-17 Warnings Exact identifier application number: M014 Bacitracin BACITRACIN NuCare Pharmaceuticals,Inc. a526ae4b-baae-5d50-e053-2a95a90ae293 2024-07-17 Warnings Exact identifier application number: M014 clotrimazole CLOTRIMAZOLE NuCare Pharmaceuticals, Inc. 54241254-1d9a-346a-e054-00144ff8d46c 2024-07-17 Warnings Exact identifier application number: M014 Dr Sheffield Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals,Inc. 5786a559-a387-120d-e053-2991aa0ab647 2024-07-15 Warnings Exact identifier application number: M014 CVS Health Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE CVS Pharmacy, Inc. 42a22e06-1b66-4359-852c-7c39e1b3940a 2024-06-24 Warnings Exact identifier application number: M014 Tolnaftate TOLNAFTATE NuCare Pharmaceuticals,Inc. 63665de7-8415-651f-e053-2991aa0ac2bb 2024-06-06 Warnings Exact identifier application number: M014 Rite Aid Earwax Removal Drops CARBAMIDE PEROXIDE Rite Aid 1262531e-0674-cf32-e063-6294a90a0d0b 2024-05-10 Warnings Exact identifier application number: M014
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