FDA.reportPublic FDA data

antibacterial hand sanitizer gel

Product NDC
82953-016
11-digit product format
829530016
Labeler code
82953
Product ID
82953-016_19a7b251-8967-dea7-e063-6394a90a08b7
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
19a7b2fc-239c-b53c-e063-6394a90a0906Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-016-01antibacterial hand sanitizer gel0115 mL in 1 BOTTLE, PLASTICGEL151
82953-016-02antibacterial hand sanitizer gel0130 mL in 1 BOTTLE, PLASTICGEL301
82953-016-03antibacterial hand sanitizer gel0160 mL in 1 BOTTLE, PLASTICGEL601
82953-016-04antibacterial hand sanitizer gel0175 mL in 1 BOTTLE, PLASTICGEL751
82953-016-05antibacterial hand sanitizer gel0135 mL in 1 BOTTLE, PLASTICGEL351
82953-016-06antibacterial hand sanitizer gel0150 mL in 1 BOTTLE, PLASTICGEL501
82953-016-07antibacterial hand sanitizer gel01120 mL in 1 BOTTLE, PLASTICGEL1201
82953-016-08antibacterial hand sanitizer gel01240 mL in 1 BOTTLE, PLASTICGEL2401
82953-016-09antibacterial hand sanitizer gel01300 mL in 1 BOTTLE, PLASTICGEL3001
82953-016-10antibacterial hand sanitizer gel0190 mL in 1 BOTTLE, PLASTICGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-016ANTIBACTERIAL HAND SANITIZER GEL 01 (ALCOHOL) GEL [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 10 package rows20240531_19a7b2fc-239c-b53c-e063-6394a90a0906.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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone-Iodine PadPOVIDONE-IODINEShandong Haiyan Medical Manufacture Co., Ltd.c9187a07-92d5-15ac-e053-2995a90af4cb2022-03-19WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Haiyan Medical Manufacture Co., Ltd.1a117840-22d0-4a88-b1a6-e43162a444ab2022-03-19WarningsExact identifier
application number: M003
FIRSTAR BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.28591a97-9291-48c8-a8e3-c419180331b32021-07-06WarningsExact identifier
application number: M003
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
application number: M003
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
application number: M003
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN19a7b2fc-239c-b53c-e063-6394a90a09061
581660ethanol 0.62 ML/ML Topical GelSCD19a7b2fc-239c-b53c-e063-6394a90a09061
581660ethanol 62 % Topical GelSY19a7b2fc-239c-b53c-e063-6394a90a09061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-016-018295300160115 mL in 1 BOTTLE, PLASTIC (82953-016-01) 15 ml2024-05-30NoNoCurrent
82953-016-028295300160230 mL in 1 BOTTLE, PLASTIC (82953-016-02) 30 ml2024-05-30NoNoCurrent
82953-016-038295300160360 mL in 1 BOTTLE, PLASTIC (82953-016-03) 60 ml2024-05-30NoNoCurrent
82953-016-048295300160475 mL in 1 BOTTLE, PLASTIC (82953-016-04) 75 ml2024-05-30NoNoCurrent
82953-016-058295300160535 mL in 1 BOTTLE, PLASTIC (82953-016-05) 35 ml2024-05-30NoNoCurrent
82953-016-068295300160650 mL in 1 BOTTLE, PLASTIC (82953-016-06) 50 ml2024-05-30NoNoCurrent
82953-016-0782953001607120 mL in 1 BOTTLE, PLASTIC (82953-016-07) 120 ml2024-05-30NoNoCurrent
82953-016-0882953001608240 mL in 1 BOTTLE, PLASTIC (82953-016-08) 240 ml2024-05-30NoNoCurrent
82953-016-0982953001609300 mL in 1 BOTTLE, PLASTIC (82953-016-09) 300 ml2024-05-30NoNoCurrent
82953-016-108295300161090 mL in 1 BOTTLE, PLASTIC (82953-016-10) 90 ml2024-05-30NoNoCurrent