FDA.reportPublic FDA data

Freskaro Ear Drops for Swimmers

Product NDC
82645-098
11-digit product format
826450098
Labeler code
82645
Product ID
82645-098_561bcc22-593f-b0e6-e063-6394a90a55fd
Type
HUMAN OTC DRUG
Nonproprietary name
Freskaro Ear Drops for Swimmers
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Pharma Nobis, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-03
Substance
GLYCERIN; ISOPROPYL ALCOHOL
Active strength
50; 950 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
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 Ear Drops for Swimmers
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN50 mg/mL
ISOPROPYL ALCOHOL950 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
631799Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f724d85-cd38-41da-e063-6394a90a9fd7Available on FDA.report

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 2 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoloEarCARBAMIDE PEROXIDEPharmadel LLC352df636-0469-c33e-e063-6294a90a22242026-03-26WarningsExact identifier
application number: M014
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
application number: M014
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
application number: M014
Ear Wash Refill CVSCARBAMIDE PEROXIDECVS311c5951-949c-b38b-e063-6294a90aa4a92026-02-27WarningsExact identifier
application number: M014
ProRinse Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Incca82db28-1ef7-41c6-a46b-7bfc7b09281c2026-02-09WarningsExact identifier
application number: M014
Wax Away Earwax Removal AidCARBAMIDE PEROXIDEMcKeon Products Inc8e6c8bf3-d3ec-4605-b8e5-47612f94db892026-02-09WarningsExact identifier
application number: M014
Wax Away Earwax Removal SystemCARBAMIDE PEROXIDEMcKeon Products Inc22c6f7db-814b-4e70-9fbe-bbb86385d0702026-02-09WarningsExact identifier
application number: M014
blue goo FREEZING PAIN RELIEF Topical AnalgesicMENTHOL 4%Garcoa, Inc.e90e35e8-47a7-4f9b-ba8a-1cfd15b439952026-02-06WarningsExact identifier
application number: M014
CaseysDishwashingSoapDISHWASHING DETERGENT JUNIPER FORESTKYNC DESIGN LLCb563af92-606c-7c12-e053-2a95a90abbb72026-01-23WarningsExact identifier
application number: M014
CaseysLavenderCASEYS HAND SOAP LAVENDER SCENTKYNC Design LLCb5bc8770-13ef-36dc-e053-2995a90a3f512026-01-23WarningsExact identifier
application number: M014
Les Coja Organic SPF 30ETHYLHEXYL SALICYLATE, HOMOSALATE, BUTYL METHOXYDIBENZOYLMETHANERNA PHARMA, LLC485d31e4-a2a9-8165-e063-6294a90a14fc2026-01-14WarningsExact identifier
application number: M014
Clinere Ear Wax RemoverCARBAMIDE PEROXIDEQuest Productsd967eac3-0aac-a7ae-e053-2995a90a0e1e2026-01-08WarningsExact identifier
application number: M014
Deluxe Ear Wash systemCARBAMIDE PEROXIDEWalgreens14923bf4-5b4f-a26a-e063-6294a90aa6b52025-12-10WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%GeriCare Pharmaceutical Corp239702af-cf93-43ee-b1af-8e53642395c12025-12-09WarningsExact identifier
application number: M014
EELHOE Whole Body Deodorant Solid BalmGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.45696491-3c41-39c6-e063-6394a90abae32025-12-07WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Peppermint Oil and Aloe ConditionerSALICYLIC ACIDRNA PHARMA, LLC450dff05-9410-5366-e063-6294a90ae0d42025-12-03WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Oil TreatmentSALICYLIC ACIDRNA PHARMA, LLC450ec8ae-2405-8d2f-e063-6394a90a50db2025-12-03WarningsExact identifier
application number: M014
Texture ID Anti Dandruff Peppermint Oil and AloeSALICYLIC ACIDRNA PHARMA, LLC44fa5eed-93e2-cb3a-e063-6294a90a3b042025-12-02WarningsExact identifier
application number: M014
Ear Wash Refill EquateCARBAMIDE PEROXIDEWalmart404619f5-4b99-03a7-e063-6294a90a3f412025-12-01WarningsExact identifier
application number: M014
JAYSUING Silicone Scar GelGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.427f80f2-e2a5-b824-e063-6294a90a95342025-11-27WarningsExact identifier
application number: M014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82645-098-91826450098911 BOTTLE, DROPPER in 1 CARTON (82645-098-91) / 30 mL in 1 BOTTLE, DROPPER2026-06-03NoNoCurrent