Ethyl alcohol

Product NDC
49035-420
11-digit product format
490350420
Labeler code
49035
Product ID
49035-420_6c4091aa-1442-4765-987d-1776a9e2a8d4
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Wal-Mart Stores, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-12-03
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
620 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-420DDiscontinued by firm2026-10-16
excluded packagepackage49035-42049035-420-10DDiscontinued by firm2026-10-16
excluded packagepackage49035-42049035-420-16DDiscontinued by firm2026-10-16

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 · 3 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 productproduct49035-420DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-42049035-420-16DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-42049035-420-10DDiscontinued 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
49035-420ETHYL ALCOHOL GEL [WAL-MART STORES, INC.]11Legacy NDC20241017_f64ff1c7-790a-4ced-8573-f805eb8cd06e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-420-104903504201029.5 mL in 1 BOTTLE, PLASTIC (49035-420-10) 29.5 ml2019-12-030000-00-00NoNoCurrent
49035-420-164903504201659 mL in 1 BOTTLE, PLASTIC (49035-420-16) 59 ml2019-12-030000-00-00NoNoCurrent