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 2 of 7 · 129 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DoloEar CARBAMIDE PEROXIDE Pharmadel LLC 352df636-0469-c33e-e063-6294a90a2224 2026-03-26 Warnings Exact identifier application number: M014 Optimel Manuka Dry Eye Drops GLYCERIN Melcare Biomedical Pty Ltd 88c5e2f0-9f7e-62d1-e053-2995a90a9014 2026-03-11 Warnings Exact identifier application number: M014 Optimel Manuka Forte Eye Gel GLYCERIN Melcare Biomedical Pty Ltd 8e0ed6e8-51fc-7c5b-e053-2a95a90a35a9 2026-03-11 Warnings Exact identifier application number: M014 Ear Wash Refill CVS CARBAMIDE PEROXIDE CVS 311c5951-949c-b38b-e063-6294a90aa4a9 2026-02-27 Warnings Exact identifier application number: M014 ProRinse Earwax Removal System CARBAMIDE PEROXIDE McKeon Products Inc ca82db28-1ef7-41c6-a46b-7bfc7b09281c 2026-02-09 Warnings Exact identifier application number: M014 Wax Away Earwax Removal Aid CARBAMIDE PEROXIDE McKeon Products Inc 8e6c8bf3-d3ec-4605-b8e5-47612f94db89 2026-02-09 Warnings Exact identifier application number: M014 Wax Away Earwax Removal System CARBAMIDE PEROXIDE McKeon Products Inc 22c6f7db-814b-4e70-9fbe-bbb86385d070 2026-02-09 Warnings Exact identifier application number: M014 blue goo FREEZING PAIN RELIEF Topical Analgesic MENTHOL 4% Garcoa, Inc. e90e35e8-47a7-4f9b-ba8a-1cfd15b43995 2026-02-06 Warnings Exact identifier application number: M014 CaseysDishwashingSoap DISHWASHING DETERGENT JUNIPER FOREST KYNC DESIGN LLC b563af92-606c-7c12-e053-2a95a90abbb7 2026-01-23 Warnings Exact identifier application number: M014 CaseysLavender CASEYS HAND SOAP LAVENDER SCENT KYNC Design LLC b5bc8770-13ef-36dc-e053-2995a90a3f51 2026-01-23 Warnings Exact identifier application number: M014 Les Coja Organic SPF 30 ETHYLHEXYL SALICYLATE, HOMOSALATE, BUTYL METHOXYDIBENZOYLMETHANE RNA PHARMA, LLC 485d31e4-a2a9-8165-e063-6294a90a14fc 2026-01-14 Warnings Exact identifier application number: M014 Clinere Ear Wax Remover CARBAMIDE PEROXIDE Quest Products d967eac3-0aac-a7ae-e053-2995a90a0e1e 2026-01-08 Warnings Exact identifier application number: M014 Deluxe Ear Wash system CARBAMIDE PEROXIDE Walgreens 14923bf4-5b4f-a26a-e063-6294a90aa6b5 2025-12-10 Warnings Exact identifier application number: M014 Ear Wax Removal Drops CARBAMIDE PEROXIDE - 6.5% GeriCare Pharmaceutical Corp 239702af-cf93-43ee-b1af-8e53642395c1 2025-12-09 Warnings Exact identifier application number: M014 EELHOE Whole Body Deodorant Solid Balm GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 45696491-3c41-39c6-e063-6394a90abae3 2025-12-07 Warnings Exact identifier application number: M014 Texture ID Anti Dandruff Peppermint Oil and Aloe Conditioner SALICYLIC ACID RNA PHARMA, LLC 450dff05-9410-5366-e063-6294a90ae0d4 2025-12-03 Warnings Exact identifier application number: M014 Texture ID Anti Dandruff Oil Treatment SALICYLIC ACID RNA PHARMA, LLC 450ec8ae-2405-8d2f-e063-6394a90a50db 2025-12-03 Warnings Exact identifier application number: M014 Texture ID Anti Dandruff Peppermint Oil and Aloe SALICYLIC ACID RNA PHARMA, LLC 44fa5eed-93e2-cb3a-e063-6294a90a3b04 2025-12-02 Warnings Exact identifier application number: M014 Ear Wash Refill Equate CARBAMIDE PEROXIDE Walmart 404619f5-4b99-03a7-e063-6294a90a3f41 2025-12-01 Warnings Exact identifier application number: M014 JAYSUING Silicone Scar Gel GLYCERIN Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. 427f80f2-e2a5-b824-e063-6294a90a9534 2025-11-27 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