Topcare Swimmers Ear Drops

Product NDC
76162-107
11-digit product format
761620107
Labeler code
76162
Product ID
76162-107_0fddeb43-fee1-d43c-e063-6394a90a738a
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Topco Associates LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-26
Substance
ISOPROPYL ALCOHOL
Active strength
95 mL/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Topcare Swimmers Ear Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL95 mL/100g

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
0fddeb43-fee0-d43c-e063-6394a90a738aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-107-01Topcare Swimmers Ear Drops1 in 1 BOXLIQUID11
76162-107-01Topcare Swimmers Ear Drops28 g in 1 BOTTLELIQUID281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-107TOPCARE SWIMMERS EAR DROPS (ISOPROPYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]1Current NDC, 2 package rows20240127_0fddeb43-fee0-d43c-e063-6394a90a738a.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN0fddeb43-fee0-d43c-e063-6394a90a738a1
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD0fddeb43-fee0-d43c-e063-6394a90a738a1
631799isopropyl alcohol 94.998 % Otic SolutionSY0fddeb43-fee0-d43c-e063-6394a90a738a1
631799isopropyl alcohol 95 % Otic SolutionSY0fddeb43-fee0-d43c-e063-6394a90a738a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-107-01761620107011 BOTTLE in 1 BOX (76162-107-01) / 28 g in 1 BOTTLE1 bottle2024-01-26NoNoCurrent