FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
53329-202
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

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 Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

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 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

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
53329-202-0453329020204118 mL in 1 BOTTLE (53329-202-04) 118 ml2015-04-060000-00-00NoNoCurrent
53329-202-0853329020208236 mL in 1 BOTTLE (53329-202-08) 236 ml2015-04-060000-00-00NoNoCurrent
53329-202-135332902021359 mL in 1 BOTTLE (53329-202-13) 59 ml2015-04-060000-00-00NoNoCurrent
53329-202-7053329020270443 mL in 1 BOTTLE (53329-202-70) 443 ml2015-04-062022-03-31NoNoCurrent
53329-202-74533290202741200 mL in 1 BOTTLE (53329-202-74) 1200 ml2023-08-01NoNoCurrent
53329-202-84533290202841000 mL in 1 BAG (53329-202-84) 1000 ml2015-04-060000-00-00NoNoCurrent
53329-202-8553329020285354 mL in 1 BOTTLE (53329-202-85) 354 ml2021-05-010000-00-00NoNoCurrent