FDA.reportPublic FDA data

Medline

Product NDC
53329-121
11-digit product format
533290121
Labeler code
53329
Product ID
53329-121_42f0f55d-fdf0-bc53-e063-6394a90accce
Type
HUMAN OTC DRUG
Nonproprietary name
ethyl alcohol
Dosage form
SWAB
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medline
Listing expiration
2026-12-31

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
1041780Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11fcc7e7-dfae-ee7d-e063-6294a90a3b31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-121-09Medline1 in 1 POUCHSWAB13
53329-121-09Medline6 mL in 1 APPLICATORSWAB63
53329-121-29Medline1 in 1 POUCHSWAB13
53329-121-29Medline50 in 1 BOXSWAB503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-121MEDLINE (ETHYL ALCOHOL) SWAB [MEDLINE INDUSTRIES, LP]2Current NDC, 4 package rows20240711_11fcc7e7-dfae-ee7d-e063-6294a90a3b31.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineETHYL ALCOHOLMedline Industries, LP11fcc7e7-dfae-ee7d-e063-6294a90a3b312025-11-06WarningsExact identifier
ndc (product): 53329-121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041780ethanol 62 % Medicated PadPSN11fcc7e7-dfae-ee7d-e063-6294a90a3b313
1041780ethanol 0.62 ML/ML Medicated PadSCD11fcc7e7-dfae-ee7d-e063-6294a90a3b313
1041780ethanol 62 % Hand Sanitizer WipesSY11fcc7e7-dfae-ee7d-e063-6294a90a3b313
1041780ethanol 62 % Medicated PadSY11fcc7e7-dfae-ee7d-e063-6294a90a3b313
1041780ethanol 62 % Topical ClothSY11fcc7e7-dfae-ee7d-e063-6294a90a3b313
1041780ethanol 62 % Topical SwabSY11fcc7e7-dfae-ee7d-e063-6294a90a3b313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-121-09533290121091 APPLICATOR in 1 POUCH (53329-121-09) / 6 mL in 1 APPLICATOR1 applicator2024-07-01NoNoCurrent
53329-121-295332901212950 POUCH in 1 BOX (53329-121-29) / 1 APPLICATOR in 1 POUCH / 6 mL in 1 APPLICATOR50 pouch2024-07-01NoNoCurrent