FDA.reportPublic FDA data

HUMCO Ear Drops for Swimmers

Product NDC
0395-0098
11-digit product format
003950098
Labeler code
0395
Product ID
0395-0098_0c929c77-c697-a582-e063-6394a90aeab1
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Humco Holding Group, Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-01-01
Substance
ISOPROPYL ALCOHOL
Active strength
950 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
HUMCO Ear Drops for Swimmers
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL950 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0098-91HUMCO Ear Drops for Swimmers1 in 1 CARTONLIQUID15
0395-0098-91HUMCO Ear Drops for Swimmers30 mL in 1 BOTTLE, PLASTICLIQUID305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0098-91ML - Milliliter0395-0098c40ffd6f-50e4-4e17-a156-50d302c559d912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0098HUMCO EAR DROPS FOR SWIMMERS (ISOPROPYL ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC.]5Current NDC, Legacy NDC, 2 package rows20231216_6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b2.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC54dc3642-0b7a-07d8-e063-6294a90ad5562026-07-22WarningsExact identifier
application number: M014
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC55057e1b-b11e-51b9-e063-6394a90a9fca2026-07-22WarningsExact identifier
application number: M014
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
application number: M014
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.c68b40d9-c1d4-4425-8063-50c00299e7182026-06-10WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.b2a641da-e070-4223-b836-5ca9ffb89f3f2026-06-10WarningsExact identifier
application number: M014
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-06-03WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal SystemCARBAMIDE PEROXIDEOaktree Products Inc.c9ad507b-341c-474f-aaa2-3c3a97a30dd82026-05-29WarningsExact identifier
application number: M014
CVS Health Earwax Removal KitCARBAMIDE PEROXIDECVS Pharmacy, Inc.f842534c-46dd-42c7-8386-9a03ce16da862026-05-29WarningsExact identifier
application number: M014
Lucid Hearing Earwax Removal Kit and BulbCARBAMIDE PEROXIDEHearing Lab Technology LLC5e09f566-397f-44d6-8ba2-90987765c7372026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEAmerisource Bergen89eac1b0-c700-45b5-8478-da53ace72e162026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDEAmerisource Bergend503b10f-85cd-4bb8-9dec-82d651d525fa2026-05-29WarningsExact identifier
application number: M014
Meijer Earwax Removal KitCARBAMIDE PEROXIDEMeijer Distribution Inc.a5f7bd55-55c3-4b0e-a16c-33bbea40536a2026-05-29WarningsExact identifier
application number: M014
Quality Choice Earwax Removal DropsCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.d8fd8102-114f-415d-9083-f98a63f9d1b32026-05-29WarningsExact identifier
application number: M014
Menthol Pain Relieving GelPAIN RELIEVING GELNeilMed Pharmaceuticals Inc513a206c-bbf6-3e51-e063-6294a90adf7a2026-05-07WarningsExact identifier
application number: M014
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
application number: M014
Freskaro Earwax Removal AidCARBAMIDE PEROXIDE 6.50% KITPharma Nobis, LLC4f5967ee-bc05-341c-e063-6394a90a35c62026-04-15WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.9a4198d2-cbea-466a-a252-d5c63d9ea0c12026-04-09WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.52f733a7-1301-4078-9267-5ce95b006ccc2026-04-09WarningsExact identifier
application number: M014
Walgreens Swimmers EarISOPROPYL ALCOHOLWalgreens Co3fb65a5c-c47f-ef2b-e063-6394a90af21a2026-04-01WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b25
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b25
631799isopropyl alcohol 94.998 % Otic SolutionSY6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b25
631799isopropyl alcohol 95 % Otic SolutionSY6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0395-0098-91003950098911 BOTTLE, PLASTIC in 1 CARTON (0395-0098-91) / 30 mL in 1 BOTTLE, PLASTIC2008-01-010000-00-00NoNoCurrent