Home NDC 68016-793 Ear Wax Removal Aid Drops
Product NDC 68016-793
11-digit product format 680160793
Labeler code 68016
Product ID 68016-793_bbd28093-02a5-4201-abf5-13670eac97e4
Type HUMAN OTC DRUG
Nonproprietary name Carbamide peroxide
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler PHARMACY VALUE ALLIANCE, LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-18
Substance CARBAMIDE PEROXIDE
Active strength .065 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Ear Wax Removal Aid Drops
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMIDE PEROXIDE .065 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-793-15 Ear Wax Removal Aid Drops 15 mL in 1 BOTTLE, DROPPER LIQUID 15 6 68016-793-15 Ear Wax Removal Aid Drops 1 in 1 CARTON LIQUID 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-793 EAR WAX REMOVAL AID DROPS (CARBAMIDE PEROXIDE) LIQUID [PHARMACY VALUE ALLIANCE, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241030_85ae80c1-2bc2-4c90-9559-63510d03e739.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 40 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Iolite BENZOCAINE Dharma Research, Inc. e4b2d22b-00b3-45a6-9b7d-8ee719587059 2023-10-09 Warnings Exact identifier application number: M022 Iolite BENZOCAINE Dharma Research, Inc. a0e284f6-292f-4231-8596-f7cee4e0a12f 2023-10-09 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC fe92637a-c88a-f9dd-e053-6294a90a7fa3 2023-07-01 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC c979e958-2042-471a-bf03-e84e68620106 2023-06-20 Warnings Exact identifier application number: M022 Orajel Gum Pain 3X Medicated BENZOCAINE, MENTHOL, ZINC CHLORIDE Church & Dwight Co., Inc. 9a1632ad-2b47-5653-e053-2995a90ae0d9 2023-01-20 Warnings Exact identifier application number: M022 KOLORZ TOPICAL ANESTHETIC TRIPLE MINT BENZOCAINE DMG AMERICA, LLC 0f90b227-f938-4e1a-a79e-1967b1a0477e 2021-10-01 Warnings Exact identifier application number: M022
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 68016-793-15 68016079315 1 BOTTLE, DROPPER in 1 CARTON (68016-793-15) / 15 mL in 1 BOTTLE, DROPPER 2019-04-18 0000-00-00 No No Current