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

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
MedlineETHYL ALCOHOLMedline Industries, LP11fcc7e7-dfae-ee7d-e063-6294a90a3b312025-11-06WarningsExact identifier
ndc (product): 53329-121

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

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