Home NDC 69842-097 Ear Drops
Product NDC 69842-097
11-digit product format 698420097
Labeler code 69842
Product ID 69842-097_0cf923ef-4234-8454-e063-6294a90afe9c
Type HUMAN OTC DRUG
Nonproprietary name Carbamide Peroxide 6.5%
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler CVS Pharmacy
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-04
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 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 69842-097-45 Ear Drops 15 mL in 1 BOTTLE, DROPPER LIQUID 15 5 69842-097-45 Ear Drops 1 in 1 CARTON LIQUID 1 5 69842-097-90 Ear Drops 1 in 1 CARTON LIQUID 1 5 69842-097-90 Ear Drops 15 mL in 1 CONTAINER LIQUID 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69842-097 EAR DROPS (CARBAMIDE PEROXIDE 6.5%) LIQUID [CVS PHARMACY] 5 Current NDC, Legacy NDC, 4 package rows 20231221_8a872991-01af-5fd0-e053-2995a90ac7f4.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 48 of 152 · 3,029 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69842-097-45 69842009745 1 BOTTLE, DROPPER in 1 CARTON (69842-097-45) / 15 mL in 1 BOTTLE, DROPPER 2019-06-04 0000-00-00 No No Current 69842-097-90 69842009790 1 CONTAINER in 1 CARTON (69842-097-90) / 15 mL in 1 CONTAINER 1 container 2019-06-04 0000-00-00 No No Current