FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
77556-580
11-digit product format
775560580
Labeler code
77556
Product ID
77556-580_473aaaa2-fbd0-c3fe-e063-6294a90a45f0
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Astera International LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-30
Marketing end
2049-12-31
Substance
ALCOHOL
Active strength
80 mL/100mL
NDC exclude flag
No
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
Hand Sanitizer

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL80 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
1039339Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5189240-19ce-7715-e053-2995a90ad043Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77556-580-01Hand Sanitizer30 mL in 1 BOTTLELIQUID309
77556-580-02Hand Sanitizer59 mL in 1 BOTTLELIQUID599
77556-580-04Hand Sanitizer118 mL in 1 BOTTLELIQUID1189
77556-580-08Hand Sanitizer236 mL in 1 BOTTLELIQUID2369
77556-580-12Hand Sanitizer354 mL in 1 BOTTLELIQUID3549
77556-580-13Hand Sanitizer400 mL in 1 BOTTLELIQUID4009
77556-580-16Hand Sanitizer473 mL in 1 BOTTLELIQUID4739
77556-580-32Hand Sanitizer946 mL in 1 BOTTLELIQUID9469
77556-580-33Hand Sanitizer1000 mL in 1 BOTTLELIQUID10009
77556-580-67Hand Sanitizer2000 mL in 1 BOTTLELIQUID20009
77556-580-93Hand Sanitizer3785 mL in 1 BOTTLELIQUID37859
77556-580-94Hand Sanitizer18927 mL in 1 CONTAINERLIQUID189279
77556-580-95Hand Sanitizer208198 mL in 1 DRUMLIQUID2081989
77556-580-97Hand Sanitizer1040990 mL in 1 TANKLIQUID10409909
77556-580-99Hand Sanitizer1249190 mL in 1 TANKLIQUID12491909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77556-580HAND SANITIZER (ALCOHOL) LIQUID [ASTERA INTERNATIONAL LLC]8Current NDC, Legacy NDC, 15 package rows20250101_a5189240-19ce-7715-e053-2995a90ad043.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 83 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEUniversal Distribution Center LLC2f98ba8c-0ab1-e256-e063-6394a90abe8f2025-03-05WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
application number: M003
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
application number: M003
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
application number: M003
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerINSTANT HAND SANITIZERRaining Rose, Inc2f37a2a1-5250-4052-e063-6294a90aef7f2025-02-28WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
application number: M003
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNa5189240-19ce-7715-e053-2995a90ad0439
1039339ethanol 0.8 ML/ML Topical SolutionSCDa5189240-19ce-7715-e053-2995a90ad0439
1039339ethanol 80 % Topical SolutionSYa5189240-19ce-7715-e053-2995a90ad0439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77556-580-017755605800130 mL in 1 BOTTLE (77556-580-01) 30 ml2020-04-302049-12-31NoNoCurrent
77556-580-027755605800259 mL in 1 BOTTLE (77556-580-02) 59 ml2020-04-302049-12-31NoNoCurrent
77556-580-0477556058004118 mL in 1 BOTTLE (77556-580-04) 118 ml2020-04-302049-12-31NoNoCurrent
77556-580-0877556058008236 mL in 1 BOTTLE (77556-580-08) 236 ml2020-04-302049-12-31NoNoCurrent
77556-580-1277556058012354 mL in 1 BOTTLE (77556-580-12) 354 ml2020-04-302049-12-31NoNoCurrent
77556-580-1377556058013400 mL in 1 BOTTLE (77556-580-13) 400 ml2020-04-302049-12-31NoNoCurrent
77556-580-1677556058016473 mL in 1 BOTTLE (77556-580-16) 473 ml2020-04-302049-12-31NoNoCurrent
77556-580-3277556058032946 mL in 1 BOTTLE (77556-580-32) 946 ml2020-04-302049-12-31NoNoCurrent
77556-580-33775560580331000 mL in 1 BOTTLE (77556-580-33) 1000 ml2020-04-302049-12-31NoNoCurrent
77556-580-67775560580672000 mL in 1 BOTTLE (77556-580-67) 2000 ml2020-04-302049-12-31NoNoCurrent
77556-580-93775560580933785 mL in 1 BOTTLE (77556-580-93) 3785 ml2020-04-302049-12-31NoNoCurrent
77556-580-947755605809418927 mL in 1 CONTAINER (77556-580-94) 18927 ml2020-04-302049-12-31NoNoCurrent
77556-580-9577556058095208198 mL in 1 DRUM (77556-580-95) 208198 ml2020-04-302049-12-31NoNoCurrent
77556-580-97775560580971040990 mL in 1 TANK (77556-580-97) 1040990 ml2020-04-302049-12-31NoNoCurrent
77556-580-99775560580991249190 mL in 1 TANK (77556-580-99) 1249190 ml2020-04-302049-12-31NoNoCurrent