FDA.reportPublic FDA data

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct53145-311EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-31153145-311-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
CARBAMIDE PEROXIDE7.8 mg/12mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31PZ2VAU81Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95920b87-941f-48cb-850c-40d2735596d4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-07-28Auralyt
2022-02-18Auralyt
2022-01-28Auralyt
2020-02-04Auralyt
2020-01-31Auralyt

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-311-04Auralyt12 mL in 1 BOTTLE, DROPPERLIQUID125
53145-311-04Auralyt1 in 1 CARTONLIQUID15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VAURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI662AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AAURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TAURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNAURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHAURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
SODIUM STANNATEINACTIVE INGREDIENTNJ7C1V83KGAURALYT (CARBAMIDE PEROXIDE) LIQUID [MENPER DISTRIBUTORS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RAURALYT (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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53145-311-04531450311041 BOTTLE, DROPPER in 1 CARTON (53145-311-04) / 12 mL in 1 BOTTLE, DROPPER2014-01-010000-00-00NoNoCurrent