Auralyt

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Auralyt
Generic name: CARBAMIDE PEROXIDE
Manufacturer: Menper Distributors, Inc
Product type: HUMAN OTC DRUG
SPL set ID: 95920b87-941f-48cb-850c-40d2735596d4
SPL ID: 3a8ad090-e1c6-7ea7-e063-6394a90a6ffc
Version: 5
Effective date: 2025-07-22
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:25:58

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M014	openfda.application_number
brand name		Auralyt	openfda.brand_name
generic name		CARBAMIDE PEROXIDE	openfda.generic_name
manufacturer name		Menper Distributors, Inc	openfda.manufacturer_name
ndc	package	53145-311-04	openfda.package_ndc
ndc	product	53145-311	openfda.product_ndc
ndc11	package	53145031104	derived:openfda.package_ndc
spl id		3a8ad090-e1c6-7ea7-e063-6394a90a6ffc	id
spl set id		95920b87-941f-48cb-850c-40d2735596d4	set_id
unii		31PZ2VAU81	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

AVOID CONTACT WITH EYES Do not use : if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy, consult a doctor if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor for more than 4 days; if excessive ear wax remains after use of this product, consult a doctor.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.