Home NDC 53329-203-04 Epi-Clenz Pure Instant Hand Antiseptic
Product NDC 53329-203
Requested package NDC 53329-203-04
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Ingredient Strength ALCOHOL 70 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 581662 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-203-04 Epi-Clenz Pure Instant Hand Antiseptic 118 mL in 1 BOTTLE GEL 118 13 53329-203-06 Epi-Clenz Pure Instant Hand Antiseptic 473 mL in 1 BOTTLE, PUMP GEL 473 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALCOHOL ACTIVE INGREDIENT 3K9958V90M EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 ALCOHOL ACTIVE MOIETY 3K9958V90M EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE, D- INACTIVE INGREDIENT A7E6112E4N EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 AMINOMETHYLPROPANOL INACTIVE INGREDIENT LU49E6626Q EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-203 EPI-CLENZ PURE INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, LP] 11 Current NDC, Legacy NDC, 2 package rows 20241116_9f2be060-0699-47ab-9398-efe91eef2267.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-203-04 53329020304 118 mL in 1 BOTTLE (53329-203-04) 118 ml 2020-04-10 0000-00-00 No No Current