FDA.reportPublic FDA data

Hand sanitizer 2oz 2pk original

Product NDC
57337-148
11-digit product format
573370148
Labeler code
57337
Product ID
57337-148_06dc1730-216b-8b4d-e063-6294a90a4184
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
2023-10-04
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
Hand sanitizer 2oz 2pk original
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
06dc1730-216a-8b4d-e063-6294a90a4184Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-148-01Hand sanitizer 2oz 2pk original59 mL in 1 BOTTLE, PLASTICGEL591
57337-148-02Hand sanitizer 2oz 2pk original59 mL in 1 BOTTLE, PLASTICGEL591
57337-148-02Hand sanitizer 2oz 2pk original2 in 1 BOXGEL21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-148HAND SANITIZER 2OZ 2PK ORIGINAL (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL CORP.]1Current NDC, 3 package rows20231004_06dc1730-216a-8b4d-e063-6294a90a4184.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 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Up and Up Max Pain Relieving CleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDETARGET CORPORATION2c3e72eb-5d98-1f3f-e063-6394a90ab00c2025-01-21WarningsExact identifier
application number: M003
Sierrasoft Clear Antibacterial Wash FoamCHLOROXYLENOLCWGC LA Inc.013a36fa-5a9a-46ea-b9d0-ac366257612e2025-01-20WarningsExact identifier
application number: M003
TM TITUS MEDICAL ANTISEPTIC Non SterilePOVIDONE-IODINETitus Medical LLC690b87d0-d889-43c6-b99e-cd9f26fd682a2025-01-17WarningsExact identifier
application number: M003
TM Titus Medical Povidone IodinePOVIDONE-IODINETitus Medical LLCaf7840c0-239e-4ff6-8d27-614e7d71ca992025-01-17WarningsExact identifier
application number: M003
Smart Care Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1b125c5d-7041-c71b-e063-6394a90add9b2025-01-17WarningsExact identifier
application number: M003
Berry Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1f128054-4c57-8055-e063-6294a90adc4e2025-01-17WarningsExact identifier
application number: M003
ROAME Moisturizing Hand Sanitizer Cloud 999ALCOHOL HAND SANITIZERRoame LLC2bb1003e-8e4c-8dd8-e063-6294a90ad37d2025-01-14WarningsExact identifier
application number: M003
Antiseptic TowelettesBENZALKONIUM CHLORIDECMC Group Inc.d7470f98-4278-415b-92e7-9eca2036bc092025-01-13WarningsExact identifier
application number: M003
Alcohol CleansingISOPROPYL ALCOHOLCMC Group Inc.e3985ef1-503a-4193-a5b5-7910aefa78142025-01-13WarningsExact identifier
application number: M003
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN06dc1730-216a-8b4d-e063-6294a90a41841
581662ethanol 0.7 ML/ML Topical GelSCD06dc1730-216a-8b4d-e063-6294a90a41841
581662ethanol 70 % Topical GelSY06dc1730-216a-8b4d-e063-6294a90a41841
581662ethyl alcohol 70 % Topical GelSY06dc1730-216a-8b4d-e063-6294a90a41841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57337-148-015733701480159 mL in 1 BOTTLE, PLASTIC (57337-148-01) 59 ml2023-10-04NoNoCurrent
57337-148-02573370148022 BOTTLE, PLASTIC in 1 BOX (57337-148-02) / 59 mL in 1 BOTTLE, PLASTIC2023-10-04NoNoCurrent