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

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 Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050, 2540674

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

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