Wax Out Plus

Product NDC
13709-313
11-digit product format
137090313
Labeler code
13709
Product ID
13709-313_0eb0da5e-0fa4-b442-e063-6394a90a08f4
Type
HUMAN OTC DRUG
Nonproprietary name
Carbamide peroxide drops
Dosage form
SOLUTION/ DROPS
Route
AURICULAR (OTIC)
Labeler
NEILMED PHARMACEUTICALS INC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-05
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
Wax Out Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMIDE PEROXIDE65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31PZ2VAU81
Rxcui702050

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-313-01Wax Out Plus1 in 1 KITSOLUTION/ DROPS12
13709-313-01Wax Out Plus15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-313WAX OUT PLUS (CARBAMIDE PEROXIDE DROPS) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 2 package rows20240112_cf64f4b8-279c-8c1d-e053-2995a90ac853.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSNcf64f4b8-279c-8c1d-e053-2995a90ac8532
702050carbamide peroxide 65 MG/ML Otic SolutionSCDcf64f4b8-279c-8c1d-e053-2995a90ac8532
702050carbamide peroxide 6.5 % Otic SolutionSYcf64f4b8-279c-8c1d-e053-2995a90ac8532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13709-313-01137090313011 BOTTLE, DROPPER in 1 KIT (13709-313-01) / 15 mL in 1 BOTTLE, DROPPER2019-10-010000-00-00NoNoCurrent