Home NDC 13709-313 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 Ingredient Strength CARBAMIDE PEROXIDE 65 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 31PZ2VAU81 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 702050 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13709-313-01 Wax Out Plus 1 in 1 KIT SOLUTION/ DROPS 1 2 13709-313-01 Wax Out Plus 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13709-313 WAX OUT PLUS (CARBAMIDE PEROXIDE DROPS) SOLUTION/ DROPS [NEILMED PHARMACEUTICALS INC] 2 Current NDC, Legacy NDC, 2 package rows 20240112_cf64f4b8-279c-8c1d-e053-2995a90ac853.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 1 of 7 · 136 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 13709-313-01 13709031301 1 BOTTLE, DROPPER in 1 KIT (13709-313-01) / 15 mL in 1 BOTTLE, DROPPER 2019-10-01 0000-00-00 No No Current