Home NDC 53145-311 Auralyt
Product NDC 53145-311
11-digit product format 531450311
Labeler code 53145
Product ID 53145-311_3a8ad090-e1c6-7ea7-e063-6394a90a6ffc
Type HUMAN OTC DRUG
Nonproprietary name Carbamide Peroxide
Dosage form LIQUID
Route TOPICAL
Labeler Menper Distributors, Inc
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-01-01
Substance CARBAMIDE PEROXIDE
Active strength 7.8 mg/12mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 53145-311 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-311 53145-311-04 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Auralyt
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMIDE PEROXIDE 7.8 mg/12mL
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-311-04 Auralyt 12 mL in 1 BOTTLE, DROPPER LIQUID 12 5 53145-311-04 Auralyt 1 in 1 CARTON LIQUID 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMIDE PEROXIDE ACTIVE INGREDIENT 31PZ2VAU81 AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 HYDROGEN PEROXIDE ACTIVE MOIETY BBX060AN9V AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 EUCALYPTUS OIL INACTIVE INGREDIENT 2R04ONI662 AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 SODIUM STANNATE INACTIVE INGREDIENT NJ7C1V83KG AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC] 1
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53145-311-04 53145031104 1 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER 2014-01-01 0000-00-00 No No Current