FDA.reportPublic FDA data

SPA HAND SANITIZER VANILLA

Product NDC
57337-187
11-digit product format
573370187
Labeler code
57337
Product ID
57337-187_47c3c187-da55-7c3b-e063-6294a90af3ce
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Rejoice International Corp.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-07
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
SPA HAND SANITIZER VANILLA
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 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
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47c3c187-da54-7c3b-e063-6294a90af3ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-187-01SPA HAND SANITIZER VANILLA236 mL in 1 BOTTLEGEL2361

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
581662ethanol 70 % Topical GelPSN47c3c187-da54-7c3b-e063-6294a90af3ce1
581662ethanol 0.7 ML/ML Topical GelSCD47c3c187-da54-7c3b-e063-6294a90af3ce1
581662ethanol 70 % Topical GelSY47c3c187-da54-7c3b-e063-6294a90af3ce1
581662ethyl alcohol 70 % Topical GelSY47c3c187-da54-7c3b-e063-6294a90af3ce1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57337-187-0157337018701236 mL in 1 BOTTLE (57337-187-01) 236 ml2026-01-07NoNoCurrent