FDA.reportPublic FDA data

OIDO SANA

Product NDC
58988-1100
11-digit product format
589881100
Labeler code
58988
Product ID
58988-1100_fd1d6b7b-081c-4b49-95f2-4a5650c9d188
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
ProMex LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-05-31
Substance
ISOPROPYL ALCOHOL
Active strength
.95 g/mL
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
OIDO SANA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL.95 g/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
71e84695-49e8-459f-ac5e-118b5235fe06Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58988-1100-12022-01-30C16284748780-1d6a99b39-bb08-a426-e053-dadaa90af4c2OIDO ® SANA
58988-1100-12022-01-28C16284748780-1d6a99b39-bb08-a426-e053-dadaa90af4c2OIDO ® SANA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58988-1100-1OIDO SANA1 in 1 CARTONSOLUTION15
58988-1100-1OIDO SANA30 mL in 1 BOTTLE, PLASTICSOLUTION305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302OIDO SANA (ISOPROPYL ALCOHOL) SOLUTION [PROMEX LLC]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302OIDO SANA (ISOPROPYL ALCOHOL) SOLUTION [PROMEX LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOIDO SANA (ISOPROPYL ALCOHOL) SOLUTION [PROMEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58988-1100OIDO SANA (ISOPROPYL ALCOHOL) SOLUTION [PROMEX LLC]5Current NDC, Legacy NDC, 2 package rows20241226_71e84695-49e8-459f-ac5e-118b5235fe06.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 4 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Best Choice Earwax Removal DropsCARBAMIDE PEROXIDEValu Merchandisers Company3ae6255f-f494-412b-af76-3579de08ed232025-02-28WarningsExact identifier
application number: M014
Equaline Earwax Removal DropsCARBAMIDE PEROXIDEUnited Natural Foodsd853567a-ce8d-40a8-be1e-27176802ff642025-02-28WarningsExact identifier
application number: M014
Family Wellness Earwax Removal Earwax and BulbCARBAMIDE PEROXIDEFamily Dollar Services Inc26ebf208-4710-4af2-aa2d-b2040b85cf852025-02-28WarningsExact identifier
application number: M014
FOSTER AND THRIVE EARWAX REMOVAL DROPSCARBAMIDE PEROXIDEA-S Medication Solutions0a571ae8-237b-447d-b697-02b30692b6b12025-02-24WarningsExact identifier
application number: M014
Pain Be GoneMENTHOLBack to Earth Inc.f49e718b-ef89-b648-e053-2a95a90a96c82025-01-29WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEMedtech Products Inc.43649ba3-75e0-4dcf-9172-23767dbaeda62025-01-27WarningsExact identifier
application number: M014
HylaTearsEYE DROPSHyalogic LLC2b5fc4c4-843c-8d3d-e063-6394a90a5a1b2025-01-10WarningsExact identifier
application number: M014
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZINGETHYL ALCOHOLRobanda International, Inc.ebec43d4-4676-40f9-b989-5381f4a737c82025-01-08WarningsExact identifier
application number: M014
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal Kit Ear wax dropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Servicesc9bd4c1f-b3b8-4bdc-b529-3a98b657e6282024-12-31WarningsExact identifier
application number: M014
Foster and Thrive Earwax Removal DropsCARBAMIDE PEROXIDEMckesson Corp. Via Strategic Sourcing Services6180835c-d7a7-4bf7-95cb-0fd3c81402532024-12-31WarningsExact identifier
application number: M014
OIDO SANAISOPROPYL ALCOHOLProMex LLC71e84695-49e8-459f-ac5e-118b5235fe062024-12-18WarningsExact identifier
application number: M014
ndc (product): 58988-1100
ERO Ear Wax Removal KitCARBAMIDE PEROXIDE 6.5%Randob Labsfbf8a6f2-531d-5047-e053-6294a90aaa012024-12-15WarningsExact identifier
application number: M014
Harris Teeter Earwax Removal DropsCARBAMIDE PEROXIDE 6.5%Harris Teeter LLCdda4c4bf-425e-4fff-e053-2a95a90a51bc2024-12-15WarningsExact identifier
application number: M014
Isopropyl AlcoholISOPROPYL ALCOHOLMazza Healthcare, LLCee83ba9f-ac65-48b7-9f84-5be6fec9a9092024-11-21WarningsExact identifier
application number: M014
Ear Wax Removal Drops Up and UpCARBAMIDE PEROXIDE - 6.5%Target Corporation829ece50-1f26-4f69-b000-010a34d4cd542024-11-21WarningsExact identifier
application number: M014
Walgreens Ear Wax RemoverCARBAMIDE PEROXIDE 6.5%Walgreens Companyd3b7362b-2826-4b86-bfa3-ef302dc791432024-11-20WarningsExact identifier
application number: M014
CLEARCANAL EAR WAX SOFTERNER DROPSCARBAMIDE PEROXIDEA-S Medication Solutionsac3d57a4-08d5-45f1-be84-f68eef9d13982024-11-04WarningsExact identifier
application number: M014
Caladryl ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEBausch Health US, LLCfca6f08b-7fa0-4ae6-bce3-61f3bcae43322024-10-17WarningsExact identifier
application number: M014
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN71e84695-49e8-459f-ac5e-118b5235fe065
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD71e84695-49e8-459f-ac5e-118b5235fe065
631799isopropyl alcohol 94.998 % Otic SolutionSY71e84695-49e8-459f-ac5e-118b5235fe065
631799isopropyl alcohol 95 % Otic SolutionSY71e84695-49e8-459f-ac5e-118b5235fe065

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58988-1100-1589881100011 BOTTLE, PLASTIC in 1 CARTON (58988-1100-1) / 30 mL in 1 BOTTLE, PLASTIC2006-05-310000-00-00NoNoCurrent