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 89 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
application number: M003
Burn TreatmentBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.9dd56b66-48c0-4bcf-a9a8-ba2f1e11ce402025-01-13WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLCMC Group Inc.dcca50e6-0935-401d-a23e-be4d1231dde92025-01-13WarningsExact identifier
application number: M003
Refill 2BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.45dde3f0-546c-4ec5-beb0-c3d0432f49832025-01-13WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
application number: M003
BACTINE MAXBACTINE MAX WOUND WASHWellSpring Pharmaceutical Corporation39b26c28-93e0-41a9-8018-f73525ebc0152025-01-08WarningsExact identifier
application number: M003
sterilePOVIDONE-IODINEAsia Dynamics Inc., d/b/a ADI Medical0658a0c8-f5ec-b380-e063-6394a90afff52025-01-08WarningsExact identifier
application number: M003
Betadine Surgical ScrubPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.1ad39e11-ea1e-44a4-8224-93f8135436c22025-01-06WarningsExact identifier
application number: M003
First Aid AntisepticBENZALKONIUM CHLORIDEWater-Jel Technologies2b3cb958-c0c4-47fd-8338-7c7821135f2b2025-01-06WarningsExact identifier
application number: M003
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact 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