Home NDC 82645-097-45 Freskaro Earwax Removal Aid
Product NDC 82645-097
Requested package NDC 82645-097-45
11-digit product format 826450097
Labeler code 82645
Product ID 82645-097_4f86b363-aff6-1bfb-e063-6394a90a317f
Type HUMAN OTC DRUG
Nonproprietary name carbamide peroxide 6.50% kit
Dosage form LIQUID
Route AURICULAR (OTIC)
Labeler Pharma Nobis, LLC
Application M014
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-13
Substance CARBAMIDE PEROXIDE
Active strength 6.5 g/100mL
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 Freskaro Earwax Removal Aid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMIDE PEROXIDE 6.5 g/100mL
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 82645-097-45 Freskaro Earwax Removal Aid 1 in 1 CARTON LIQUID 1 2 82645-097-45 Freskaro Earwax Removal Aid 15 mL in 1 BOTTLE, DROPPER LIQUID 15 2 82645-097-90 Freskaro Earwax Removal Aid 1 in 1 CARTON LIQUID 1 2 82645-097-90 Freskaro Earwax Removal Aid 15 mL in 1 BOTTLE, DROPPER LIQUID 15 2
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 · 128 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ClearCanal Ear Wax Softerner Drops CARBAMIDE PEROXIDE NeilMed Pharmaceuticals, Inc. 0ef2be5b-cc39-48ae-b5c5-e787464dea08 2026-08-17 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 54dc3642-0b7a-07d8-e063-6294a90ad556 2026-07-22 Warnings Exact identifier application number: M014 EarBalance Ear Pain Drops LIDOCAINE HYDROCHLORIDE OTIC SOLUTION Marie's Original Formulas LLC 55057e1b-b11e-51b9-e063-6394a90a9fca 2026-07-22 Warnings Exact identifier application number: M014 Freskaro Ear Drops for Swimmers FRESKARO EAR DROPS FOR SWIMMERS Pharma Nobis, LLC 4f724d85-cd38-41da-e063-6394a90a9fd7 2026-07-08 Warnings Exact identifier application number: M014 Macks Dry n Clear EAR DRYING AID McKeon Products Inc 1ea1da54-2412-c25c-e063-6294a90aa264 2026-06-26 Warnings Exact identifier application number: M014 Equate Swimmers Instant Ear Dry EQUATE SWIMMERS INSTANT EAR DRY Walmart Stores, Inc 76b58a7a-48cf-866c-e053-2a91aa0a7e63 2026-06-26 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops Earwax Removal Aid CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. c68b40d9-c1d4-4425-8063-50c00299e718 2026-06-10 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. b2a641da-e070-4223-b836-5ca9ffb89f3f 2026-06-10 Warnings Exact identifier application number: M014 Audiologists Choice Earwax Removal System CARBAMIDE PEROXIDE Oaktree Products Inc. c9ad507b-341c-474f-aaa2-3c3a97a30dd8 2026-05-29 Warnings Exact identifier application number: M014 CVS Health Earwax Removal Kit CARBAMIDE PEROXIDE CVS Pharmacy, Inc. f842534c-46dd-42c7-8386-9a03ce16da86 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Amerisource Bergen 89eac1b0-c700-45b5-8478-da53ace72e16 2026-05-29 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal CARBAMIDE PEROXIDE Amerisource Bergen d503b10f-85cd-4bb8-9dec-82d651d525fa 2026-05-29 Warnings Exact identifier application number: M014 Meijer Earwax Removal Kit CARBAMIDE PEROXIDE Meijer Distribution Inc. a5f7bd55-55c3-4b0e-a16c-33bbea40536a 2026-05-29 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Drops CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. d8fd8102-114f-415d-9083-f98a63f9d1b3 2026-05-29 Warnings Exact identifier application number: M014 Menthol Pain Relieving Gel PAIN RELIEVING GEL NeilMed Pharmaceuticals Inc 513a206c-bbf6-3e51-e063-6294a90adf7a 2026-05-07 Warnings Exact identifier application number: M014 Freskaro Earwax Removal Aid CARBAMIDE PEROXIDE 6.50% KIT Pharma Nobis, LLC 4f5967ee-bc05-341c-e063-6394a90a35c6 2026-04-15 Warnings Exact identifier application number: M014 ndc (package): 82645-097-45 ndc (product): 82645-097 ndc11 (package): 82645009745 GoodSense Ear Wax Removal Kit CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 9a4198d2-cbea-466a-a252-d5c63d9ea0c1 2026-04-09 Warnings Exact identifier application number: M014 Good Neighbor Pharmacy Earwax Removal Drops CARBAMIDE PEROXIDE Preferred Pharmaceuticals Inc. 52f733a7-1301-4078-9267-5ce95b006ccc 2026-04-09 Warnings Exact identifier application number: M014 Walgreens Swimmers Ear ISOPROPYL ALCOHOL Walgreens Co 3fb65a5c-c47f-ef2b-e063-6394a90af21a 2026-04-01 Warnings Exact identifier application number: M014 DoloEar CARBAMIDE PEROXIDE Pharmadel LLC 352df636-0469-c33e-e063-6294a90a2224 2026-03-26 Warnings Exact identifier application number: M014
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82645-097-45 82645009745 1 BOTTLE, DROPPER in 1 CARTON (82645-097-45) / 15 mL in 1 BOTTLE, DROPPER 2026-04-15 No No Current