FDA.reportPublic FDA data

Ethyl Alcohol

Product NDC
62011-0353
11-digit product format
620110353
Labeler code
62011
Product ID
62011-0353_3791289f-dc7e-4690-93a9-6e821e90d7dc
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-05-18
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
610 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0353DDiscontinued by firm2026-10-05
excluded packagepackage62011-035362011-0353-1DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct62011-0353DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-035362011-0353-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0353ETHYL ALCOHOL LIQUID [STRATEGIC SOURCING SERVICES LLC]15Legacy NDC20240713_714ef357-6a28-4988-bced-a155bede98df.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0353-162011035301473 mL in 1 BOTTLE, PLASTIC (62011-0353-1) 473 ml2009-05-180000-00-00NoNoCurrent