FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Product NDC
71160-188
Requested package NDC
71160-188-12
11-digit product format
711600188
Labeler code
71160
Product ID
71160-188_0ec200c0-eac3-08fb-e063-6294a90a2fde
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
TEKWELD INC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-15
Substance
ALCOHOL
Active strength
62 mL/100mL
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
ALCOHOL62 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
247835Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8dcfaed-9b3d-4c7a-a93e-407c7f62051fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-188-12Antibacterial Hand Sanitizer12 mL in 1 BOTTLELIQUID121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-188ANTIBACTERIAL HAND SANITIZER (ALCOHOL) LIQUID [TEKWELD INC]1Current NDC, 1 package rows20240215_f8dcfaed-9b3d-4c7a-a93e-407c7f62051f.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 INCf8dcfaed-9b3d-4c7a-a93e-407c7f62051f2024-01-12WarningsExact identifier
ndc (package): 71160-188-12
ndc (product): 71160-188
ndc11 (package): 71160018812

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
247835ethanol 62 % Topical SolutionPSNf8dcfaed-9b3d-4c7a-a93e-407c7f62051f1
247835ethanol 0.62 ML/ML Topical SolutionSCDf8dcfaed-9b3d-4c7a-a93e-407c7f62051f1
247835ethanol 62 % Topical SolutionSYf8dcfaed-9b3d-4c7a-a93e-407c7f62051f1
247835ethyl alcohol 62 % Topical SolutionSYf8dcfaed-9b3d-4c7a-a93e-407c7f62051f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71160-188-127116001881212 mL in 1 BOTTLE (71160-188-12) 12 ml2024-02-15NoNoCurrent