FDA.reportPublic FDA data

Medline

Product NDC
53329-230
11-digit product format
533290230
Labeler code
53329
Product ID
53329-230_4874c787-bdf5-63f7-e063-6294a90a93d9
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-08
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 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
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48741464-df0d-f963-e063-6394a90a0322Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-230-02Medline2.4 mL in 1 PACKETGEL2.42
53329-230-04Medline118 mL in 1 BOTTLEGEL1182
53329-230-08Medline236 mL in 1 BOTTLE, PUMPGEL2362
53329-230-13Medline59 mL in 1 BOTTLEGEL592
53329-230-85Medline354 mL in 1 BOTTLE, PUMPGEL3542

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, LP48741464-df0d-f963-e063-6394a90a03222026-04-08WarningsExact identifier
ndc (product): 53329-230

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN48741464-df0d-f963-e063-6394a90a03222
581662ethanol 0.7 ML/ML Topical GelSCD48741464-df0d-f963-e063-6394a90a03222
581662ethanol 70 % Topical GelSY48741464-df0d-f963-e063-6394a90a03222
581662ethyl alcohol 70 % Topical GelSY48741464-df0d-f963-e063-6394a90a03222

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-230-02533290230022.4 mL in 1 PACKET (53329-230-02) 2.4 ml2026-04-08NoNoCurrent
53329-230-0453329023004118 mL in 1 BOTTLE (53329-230-04) 118 ml2026-04-08NoNoCurrent
53329-230-0853329023008236 mL in 1 BOTTLE, PUMP (53329-230-08) 236 ml2026-04-08NoNoCurrent
53329-230-135332902301359 mL in 1 BOTTLE (53329-230-13) 59 ml2026-04-08NoNoCurrent
53329-230-8553329023085354 mL in 1 BOTTLE, PUMP (53329-230-85) 354 ml2026-04-08NoNoCurrent