FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Product NDC
71160-180
11-digit product format
711600180
Labeler code
71160
Product ID
71160-180_285edb29-9a5c-40ee-e063-6394a90adabb
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
TEKWELD SOLUTIONS, INC.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-09
Substance
ALCOHOL
Active strength
620 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL620 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581660

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-180-15Antibacterial Hand Sanitizer15 mL in 1 BOTTLEGEL1511
71160-180-29Antibacterial Hand Sanitizer29 mL in 1 BOTTLEGEL2911
71160-180-30Antibacterial Hand Sanitizer30 mL in 1 BOTTLEGEL3011
71160-180-53Antibacterial Hand Sanitizer53 mL in 1 BOTTLEGEL5311
71160-180-58Antibacterial Hand Sanitizer58 mL in 1 BOTTLEGEL5811
71160-180-59Antibacterial Hand Sanitizer59 mL in 1 BOTTLEGEL5911
71160-180-60Antibacterial Hand Sanitizer60 mL in 1 BOTTLEGEL6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-180ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [TEKWELD SOLUTIONS, INC.]11Current NDC, Legacy NDC, 7 package rows20241205_45afc52b-9838-1729-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN45afc52b-9838-1729-e054-00144ff8d46c11
581660ethanol 0.62 ML/ML Topical GelSCD45afc52b-9838-1729-e054-00144ff8d46c11
581660ethanol 62 % Topical GelSY45afc52b-9838-1729-e054-00144ff8d46c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71160-180-157116001801515 mL in 1 BOTTLE (71160-180-15) 15 ml2024-02-15NoNoCurrent
71160-180-297116001802929 mL in 1 BOTTLE (71160-180-29) 29 ml2017-01-090000-00-00NoNoCurrent
71160-180-307116001803030 mL in 1 BOTTLE (71160-180-30) 30 ml2024-02-15NoNoCurrent
71160-180-537116001805353 mL in 1 BOTTLE (71160-180-53) 53 ml2024-12-30NoNoCurrent
71160-180-587116001805858 mL in 1 BOTTLE (71160-180-58) 58 ml2024-02-15NoNoCurrent
71160-180-597116001805959 mL in 1 BOTTLE (71160-180-59) 59 ml2017-01-090000-00-00NoNoCurrent
71160-180-607116001806060 mL in 1 BOTTLE (71160-180-60) 60 ml2024-02-15NoNoCurrent