FDA.reportPublic FDA data

Equate Swimmers Instant Ear Dry

Product NDC
49035-989
11-digit product format
490350989
Labeler code
49035
Product ID
49035-989_55287f2f-48de-9d94-e063-6394a90a14a4
Type
HUMAN OTC DRUG
Nonproprietary name
Equate Swimmers Instant Ear Dry
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Walmart Stores, Inc
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-25
Substance
ISOPROPYL ALCOHOL
Active strength
950 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
Equate Swimmers Instant Ear Dry
Listing expiration
2027-12-31

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
76b58a7a-48cf-866c-e053-2a91aa0a7e63Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-989-91Equate Swimmers Instant Ear Dry30 mL in 1 CONTAINERLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-989EQUATE SWIMMERS INSTANT EAR DRY LIQUID [WALMART STORES, INC]6Current NDC, Legacy NDC, 1 package rows20231220_76b58a7a-48cf-866c-e053-2a91aa0a7e63.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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN76b58a7a-48cf-866c-e053-2a91aa0a7e636
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD76b58a7a-48cf-866c-e053-2a91aa0a7e636
631799isopropyl alcohol 94.998 % Otic SolutionSY76b58a7a-48cf-866c-e053-2a91aa0a7e636
631799isopropyl alcohol 95 % Otic SolutionSY76b58a7a-48cf-866c-e053-2a91aa0a7e636

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-989-914903509899130 mL in 1 CONTAINER (49035-989-91) 30 ml2018-09-250000-00-00NoNoCurrent