FDA.reportPublic FDA data

SuavEar Earwax Removal Aid

Product NDC
13709-312
11-digit product format
137090312
Labeler code
13709
Product ID
13709-312_0eb0ee15-bb9f-bd77-e063-6394a90a0df7
Type
HUMAN OTC DRUG
Nonproprietary name
Earwax Removal Aid
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
NEILMED PHARMACEUTICALS INC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-22
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
SuavEar Earwax Removal Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702050Internal RxNorm lookup
2540674Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c067f1a4-1f67-3f4d-e053-2a95a90a6095Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-312-01SuavEar Earwax Removal Aid15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152
13709-312-01SuavEar Earwax Removal Aid1 in 1 KITSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-312SUAVEAR EARWAX REMOVAL AID (EARWAX REMOVAL AID) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20240112_c067f1a4-1f67-3f4d-e053-2a95a90a6095.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNc067f1a4-1f67-3f4d-e053-2a95a90a60952
2540674SuavEar Earwax Removal Aid 6.5 % Otic SolutionPSNc067f1a4-1f67-3f4d-e053-2a95a90a60952
2540674carbamide peroxide 65 MG/ML Otic Solution [Suavear]SBDc067f1a4-1f67-3f4d-e053-2a95a90a60952
702050carbamide peroxide 65 MG/ML Otic SolutionSCDc067f1a4-1f67-3f4d-e053-2a95a90a60952
702050carbamide peroxide 6.5 % Otic SolutionSYc067f1a4-1f67-3f4d-e053-2a95a90a60952
2540674SuavEar 6.5 % Otic SolutionSYc067f1a4-1f67-3f4d-e053-2a95a90a60952
2540674SuavEar 65 MG/ML Otic SolutionSYc067f1a4-1f67-3f4d-e053-2a95a90a60952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13709-312-01137090312011 BOTTLE, DROPPER in 1 KIT (13709-312-01) / 15 mL in 1 BOTTLE, DROPPER2021-04-220000-00-00NoNoCurrent