Epi-Clenz Pure Instant Hand Antiseptic

Product NDC
53329-203
11-digit product format
533290203
Labeler code
53329
Product ID
53329-203_48343359-a967-5327-e063-6294a90a54e5
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
2012-04-02
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
Epi-Clenz Pure Instant Hand Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-203-04Epi-Clenz Pure Instant Hand Antiseptic118 mL in 1 BOTTLEGEL11813
53329-203-06Epi-Clenz Pure Instant Hand Antiseptic473 mL in 1 BOTTLE, PUMPGEL47313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-203EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, LP]11Current NDC, Legacy NDC, 2 package rows20241116_9f2be060-0699-47ab-9398-efe91eef2267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN9f2be060-0699-47ab-9398-efe91eef226713
581662ethanol 0.7 ML/ML Topical GelSCD9f2be060-0699-47ab-9398-efe91eef226713
581662ethanol 70 % Topical GelSY9f2be060-0699-47ab-9398-efe91eef226713
581662ethyl alcohol 70 % Topical GelSY9f2be060-0699-47ab-9398-efe91eef226713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-203-0453329020304118 mL in 1 BOTTLE (53329-203-04) 118 ml2020-04-100000-00-00NoNoCurrent
53329-203-0653329020306473 mL in 1 BOTTLE, PUMP (53329-203-06) 473 ml2012-04-020000-00-00NoNoCurrent