FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Product NDC
71160-180
Requested package NDC
71160-180-30
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

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
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
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45afc52b-9838-1729-e054-00144ff8d46cAvailable on FDA.report

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

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.45afc52b-9838-1729-e054-00144ff8d46c2024-12-03WarningsExact identifier
ndc (package): 71160-180-30
ndc (product): 71160-180
ndc11 (package): 71160018030

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 startSampleExclude flagStatus
71160-180-307116001803030 mL in 1 BOTTLE (71160-180-30) 30 ml2024-02-15NoNoCurrent