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 Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

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

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