FDA.reportPublic FDA data

antibacterial hand sanitizer gel

Product NDC
82953-022
11-digit product format
829530022
Labeler code
82953
Product ID
82953-022_202e57ae-528d-b399-e063-6394a90aadca
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-30
Substance
ALCOHOL
Active strength
62 mL/100mL
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 gel
Brand name suffix
01
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
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
202e5c15-8749-0a76-e063-6294a90a2720Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-022-01antibacterial hand sanitizer gel0115 mL in 1 BOTTLE, PLASTICGEL151
82953-022-02antibacterial hand sanitizer gel0130 mL in 1 BOTTLE, PLASTICGEL301
82953-022-03antibacterial hand sanitizer gel0160 mL in 1 BOTTLE, PLASTICGEL601
82953-022-04antibacterial hand sanitizer gel0175 mL in 1 BOTTLE, PLASTICGEL751
82953-022-05antibacterial hand sanitizer gel0135 mL in 1 BOTTLE, PLASTICGEL351
82953-022-06antibacterial hand sanitizer gel0150 mL in 1 BOTTLE, PLASTICGEL501
82953-022-07antibacterial hand sanitizer gel01120 mL in 1 BOTTLE, PLASTICGEL1201
82953-022-08antibacterial hand sanitizer gel01240 mL in 1 BOTTLE, PLASTICGEL2401
82953-022-09antibacterial hand sanitizer gel01300 mL in 1 BOTTLE, PLASTICGEL3001
82953-022-10antibacterial hand sanitizer gel0190 mL in 1 BOTTLE, PLASTICGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-022ANTIBACTERIAL HAND SANITIZER GEL 01 (ALCOHOL) GEL [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 10 package rows20240822_202e5c15-8749-0a76-e063-6294a90a2720.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
581660ethanol 62 % Topical GelPSN202e5c15-8749-0a76-e063-6294a90a27201
581660ethanol 0.62 ML/ML Topical GelSCD202e5c15-8749-0a76-e063-6294a90a27201
581660ethanol 62 % Topical GelSY202e5c15-8749-0a76-e063-6294a90a27201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-022-018295300220115 mL in 1 BOTTLE, PLASTIC (82953-022-01) 15 ml2024-05-30NoNoCurrent
82953-022-028295300220230 mL in 1 BOTTLE, PLASTIC (82953-022-02) 30 ml2024-05-30NoNoCurrent
82953-022-038295300220360 mL in 1 BOTTLE, PLASTIC (82953-022-03) 60 ml2024-05-30NoNoCurrent
82953-022-048295300220475 mL in 1 BOTTLE, PLASTIC (82953-022-04) 75 ml2024-05-30NoNoCurrent
82953-022-058295300220535 mL in 1 BOTTLE, PLASTIC (82953-022-05) 35 ml2024-05-30NoNoCurrent
82953-022-068295300220650 mL in 1 BOTTLE, PLASTIC (82953-022-06) 50 ml2024-05-30NoNoCurrent
82953-022-0782953002207120 mL in 1 BOTTLE, PLASTIC (82953-022-07) 120 ml2024-05-30NoNoCurrent
82953-022-0882953002208240 mL in 1 BOTTLE, PLASTIC (82953-022-08) 240 ml2024-05-30NoNoCurrent
82953-022-0982953002209300 mL in 1 BOTTLE, PLASTIC (82953-022-09) 300 ml2024-05-30NoNoCurrent
82953-022-108295300221090 mL in 1 BOTTLE, PLASTIC (82953-022-10) 90 ml2024-05-30NoNoCurrent