FDA.reportPublic FDA data

Ethyl alcohol

Product NDC
49035-418
Requested package NDC
49035-418-10
11-digit product format
490350418
Labeler code
49035
Product ID
49035-418_4bd2e99d-5e97-e02c-e063-6294a90a6555
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Walmart Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-03
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ethyl alcoholETHYL ALCOHOLWalmart Inc.f7d9bb83-0b80-458b-9554-8adbe51473e42026-02-27Warnings, Adverse reactionsExact identifier
ndc (package): 49035-418-10
ndc (product): 49035-418
ndc11 (package): 49035041810

Additional Listing Data#

Finished product
Yes
Brand name base
Ethyl alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7d9bb83-0b80-458b-9554-8adbe51473e4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-418-10Ethyl alcohol29.5 mL in 1 PACKAGEGEL29.518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-418ETHYL ALCOHOL GEL [WALMART INC.]17Current NDC, Legacy NDC, 1 package rows20250330_f7d9bb83-0b80-458b-9554-8adbe51473e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNf7d9bb83-0b80-458b-9554-8adbe51473e418
581660ethanol 0.62 ML/ML Topical GelSCDf7d9bb83-0b80-458b-9554-8adbe51473e418
581660ethanol 62 % Topical GelSYf7d9bb83-0b80-458b-9554-8adbe51473e418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-418-104903504181029.5 mL in 1 PACKAGE (49035-418-10) 29.5 ml2019-12-030000-00-00NoNoCurrent