Home NDC 63029-321 DEBROX
Product NDC 63029-321
11-digit product format 630290321
Labeler code 63029
Product ID 63029-321_69ef758d-a912-4696-8f5e-ac6cd1aa63dc
Type HUMAN OTC DRUG
Nonproprietary name Carbamide Peroxide
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler Medtech Products Inc.
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-08-01
Substance CARBAMIDE PEROXIDE
Active strength 65 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 DEBROX
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 702050 Internal RxNorm lookup 827654 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 63029-321-01 DEBROX 15 mL in 1 BOTTLE, DROPPER LIQUID 15 3 63029-321-01 DEBROX 1 in 1 CARTON LIQUID 1 3 63029-321-02 DEBROX 1 in 1 CARTON LIQUID 1 3 63029-321-02 DEBROX 15 mL in 1 BOTTLE, DROPPER LIQUID 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63029-321 DEBROX (CARBAMIDE PEROXIDE) LIQUID [MEDTECH PRODUCTS INC.] 3 Current NDC, Legacy NDC, 4 package rows 20250124_43649ba3-75e0-4dcf-9172-23767dbaeda6.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 5 of 7 · 129 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Debrox Kids ISOPROPYL ALCOHOL Medtech Products Inc. f42eee70-c4ee-44ad-85d5-a06d98ecb8b0 2024-05-09 Warnings Exact identifier application number: M014 Rite Aid Swimmers Ear Drops ISOPROPYL ALCOHOL Rite Aid 12875b9d-3ae8-bd0c-e063-6294a90ab4ae 2024-02-29 Warnings Exact identifier application number: M014 Topcare Swimmers Ear Drops ISOPROPYL ALCOHOL Topco Associates LLC 0fddeb43-fee0-d43c-e063-6394a90a738a 2024-01-26 Warnings Exact identifier application number: M014 NeilMed Clear Canal Earwax Removal kit CARBAMIDE PEROXIDE NEILMED PHARMACEUTICALS INC d330552d-07b6-f01e-e053-2a95a90a7ca5 2024-01-11 Warnings Exact identifier application number: M014 Wax Out Plus CARBAMIDE PEROXIDE DROPS NEILMED PHARMACEUTICALS INC cf64f4b8-279c-8c1d-e053-2995a90ac853 2024-01-11 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 Marketing end Sample Exclude flag Status 63029-321-01 63029032101 1 BOTTLE, DROPPER in 1 CARTON (63029-321-01) / 15 mL in 1 BOTTLE, DROPPER 2012-08-01 0000-00-00 No No Current 63029-321-02 63029032102 1 BOTTLE, DROPPER in 1 CARTON (63029-321-02) / 15 mL in 1 BOTTLE, DROPPER 2012-08-01 No No Current