FDA.reportPublic FDA data

Applause

Product NDC
67858-693
11-digit product format
678580693
Labeler code
67858
Product ID
67858-693_28c533c1-0cf6-d184-e063-6294a90aeb64
Type
HUMAN OTC DRUG
Nonproprietary name
Instant Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
QuestSpecialty Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-02
Substance
ALCOHOL
Active strength
3 g/5g
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
Applause
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL3 g/5g

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
581658Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
774657f1-5c39-2fed-e053-2991aa0a9064Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67858-693-01Applause107 g in 1 BOTTLEGEL1079
67858-693-02Applause24 in 1 CARTONGEL249
67858-693-03Applause212 g in 1 BOTTLE, PLASTICGEL2129
67858-693-04Applause12 in 1 CARTONGEL129
67858-693-05Applause3407 g in 1 BOTTLE, PLASTICGEL34079
67858-693-06Applause4 in 1 CARTONGEL49
67858-693-07Applause187358 g in 1 DRUMGEL1873589
67858-693-08Applause424 g in 1 BOTTLE, PLASTICGEL4249
67858-693-09Applause12 in 1 CARTONGEL129

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67858-693APPLAUSE (INSTANT HAND SANITIZER) GEL [QUESTSPECIALTY CORPORATION]9Current NDC, Legacy NDC, 9 package rows20241209_774657f1-5c39-2fed-e053-2991aa0a9064.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ApplauseINSTANT HAND SANITIZERQuestSpecialty Corporation774657f1-5c39-2fed-e053-2991aa0a90642024-12-08WarningsExact identifier
ndc (product): 67858-693

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581658ethanol 60 % Topical GelPSN774657f1-5c39-2fed-e053-2991aa0a90649
581658ethanol 0.6 ML/ML Topical GelSCD774657f1-5c39-2fed-e053-2991aa0a90649
581658ethanol 60 % Topical GelSY774657f1-5c39-2fed-e053-2991aa0a90649

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67858-693-0167858069301107 g in 1 BOTTLE107 gHistorical
67858-693-026785806930224 BOTTLE in 1 CARTON (67858-693-02) / 107 g in 1 BOTTLE (67858-693-01) 24 bottle2018-10-020000-00-00NoNoCurrent
67858-693-0367858069303212 g in 1 BOTTLE, PLASTIC212 gHistorical
67858-693-046785806930412 BOTTLE, PLASTIC in 1 CARTON (67858-693-04) / 212 g in 1 BOTTLE, PLASTIC (67858-693-03) 2018-10-020000-00-00NoNoCurrent
67858-693-05678580693053407 g in 1 BOTTLE, PLASTIC3407 gHistorical
67858-693-06678580693064 BOTTLE, PLASTIC in 1 CARTON (67858-693-06) / 3407 g in 1 BOTTLE, PLASTIC (67858-693-05) 2018-10-020000-00-00NoNoCurrent
67858-693-0767858069307187358 g in 1 DRUM (67858-693-07) 187358 g2018-10-020000-00-00NoNoCurrent
67858-693-0867858069308424 g in 1 BOTTLE, PLASTIC424 gHistorical
67858-693-096785806930912 BOTTLE, PLASTIC in 1 CARTON (67858-693-09) / 424 g in 1 BOTTLE, PLASTIC (67858-693-08) 2021-01-01NoNoCurrent
67858-693-246785806932412 BOTTLE in 1 CARTON (67858-693-24) > 107 g in 1 BOTTLE (67858-693-04) 12 bottle2018-10-020000-00-00NoNoCurrent