FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
53329-202
Requested package NDC
53329-202-85
11-digit product format
533290202
Labeler code
53329
Product ID
53329-202_4a8e1ef2-4cd3-a9a9-e063-6394a90a3990
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
2015-04-06
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
Hand Sanitizer
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
f84f7050-348d-4f75-ab93-e618ff8de790Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-202-04Hand Sanitizer118 mL in 1 BOTTLEGEL11811
53329-202-08Hand Sanitizer236 mL in 1 BOTTLEGEL23611
53329-202-13Hand Sanitizer59 mL in 1 BOTTLEGEL5911
53329-202-70Hand Sanitizer443 mL in 1 BOTTLEGEL44311
53329-202-74Hand Sanitizer1200 mL in 1 BOTTLEGEL120011
53329-202-84Hand Sanitizer1000 mL in 1 BAGGEL100011
53329-202-85Hand Sanitizer354 mL in 1 BOTTLEGEL35411

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1
ALCOHOLACTIVE MOIETY3K9958V90MHAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NHAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RHAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-202HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, LP]9Current NDC, Legacy NDC, 7 package rows20240531_f84f7050-348d-4f75-ab93-e618ff8de790.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerETHYL ALCOHOLMedline Industries, LPf84f7050-348d-4f75-ab93-e618ff8de7902026-02-11WarningsExact identifier
ndc (package): 53329-202-85
ndc (product): 53329-202
ndc11 (package): 53329020285

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNf84f7050-348d-4f75-ab93-e618ff8de79011
581662ethanol 0.7 ML/ML Topical GelSCDf84f7050-348d-4f75-ab93-e618ff8de79011
581662ethanol 70 % Topical GelSYf84f7050-348d-4f75-ab93-e618ff8de79011
581662ethyl alcohol 70 % Topical GelSYf84f7050-348d-4f75-ab93-e618ff8de79011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-202-8553329020285354 mL in 1 BOTTLE (53329-202-85) 354 ml2021-05-010000-00-00NoNoCurrent