FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Product NDC
71160-189
11-digit product format
711600189
Labeler code
71160
Product ID
71160-189_10ab6d24-091c-0407-e063-6394a90a5d6b
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
SPRAY
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 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
1020364Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
45af86a4-a413-0309-e054-00144ff88e88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-189-05Antibacterial Hand Sanitizer5 mL in 1 BOTTLESPRAY58
71160-189-10Antibacterial Hand Sanitizer10 mL in 1 BOTTLESPRAY108
71160-189-20Antibacterial Hand Sanitizer20 mL in 1 BOTTLESPRAY208
71160-189-25Antibacterial Hand Sanitizer25 mL in 1 BOTTLESPRAY258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-189ANTIBACTERIAL HAND SANITIZER (ALCOHOL) SPRAY [TEKWELD SOLUTIONS, INC.]8Current NDC, Legacy NDC, 4 package rows20240207_45af86a4-a413-0309-e054-00144ff88e88.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
Antibacterial Hand SanitizerALCOHOLTEKWELD SOLUTIONS, INC.45af86a4-a413-0309-e054-00144ff88e882024-02-05WarningsExact identifier
ndc (product): 71160-189

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020364ethanol 62 % Topical SprayPSN45af86a4-a413-0309-e054-00144ff88e888
1020364ethanol 0.62 ML/ML Topical SpraySCD45af86a4-a413-0309-e054-00144ff88e888
1020364ethanol 62 % Topical SpraySY45af86a4-a413-0309-e054-00144ff88e888
1020364ethyl alcohol 62 % Topical SpraySY45af86a4-a413-0309-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71160-189-05711600189055 mL in 1 BOTTLE (71160-189-05) 5 ml2017-01-090000-00-00NoNoCurrent
71160-189-107116001891010 mL in 1 BOTTLE (71160-189-10) 10 ml2017-01-090000-00-00NoNoCurrent
71160-189-207116001892020 mL in 1 BOTTLE (71160-189-20) 20 ml2017-01-090000-00-00NoNoCurrent
71160-189-257116001892525 mL in 1 BOTTLE (71160-189-25) 25 ml2017-01-090000-00-00NoNoCurrent