FDA.reportPublic FDA data

Auro Dri

Product NDC
63736-327
11-digit product format
637360327
Labeler code
63736
Product ID
63736-327_5c04bc18-9f89-4c70-e063-6394a90a90b6
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
AURICULAR (OTIC)
Labeler
Insight Pharmaceuticals LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-14
Marketing end
2027-07-31
Substance
ISOPROPYL ALCOHOL
Active strength
95 mL/100mL
NDC exclude flag
No
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
Auro Dri

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL95 mL/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-327-12Auro Dri1 in 1 BOXLIQUID15
63736-327-12Auro Dri12 in 1 CASELIQUID125
63736-327-24Auro Dri24 in 1 CASELIQUID245
63736-327-24Auro Dri1 in 1 BOXLIQUID15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Isopropyl AlcoholACTIVE INGREDIENTND2M416302AURO-DRI (ISOPROPYL ALCOHOL) LIQUID [INSIGHT PHARMACEUTICALS]1
Isopropyl AlcoholACTIVE MOIETYND2M416302AURO-DRI (ISOPROPYL ALCOHOL) LIQUID [INSIGHT PHARMACEUTICALS]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXAURO-DRI (ISOPROPYL ALCOHOL) LIQUID [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-327AURO DRI (ISOPROPYL ALCOHOL) LIQUID [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 4 package rows20241105_85cb4973-6a81-4d8f-b187-4bf709d93a98.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 SolutionPSN85cb4973-6a81-4d8f-b187-4bf709d93a985
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD85cb4973-6a81-4d8f-b187-4bf709d93a985
631799isopropyl alcohol 94.998 % Otic SolutionSY85cb4973-6a81-4d8f-b187-4bf709d93a985
631799isopropyl alcohol 95 % Otic SolutionSY85cb4973-6a81-4d8f-b187-4bf709d93a985

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-327-126373603271212 BOX in 1 CASE (63736-327-12) / 1 BOTTLE in 1 BOX / 29 mL in 1 BOTTLE12 box2010-06-142027-07-31NoNoCurrent
63736-327-246373603272424 BOX in 1 CASE (63736-327-24) / 1 BOTTLE in 1 BOX / 29 mL in 1 BOTTLE24 box2010-06-142027-04-30NoNoCurrent