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

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 Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581658

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

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) 2021-01-01NoNoHistorical
67858-693-246785806932412 BOTTLE in 1 CARTON (67858-693-24) > 107 g in 1 BOTTLE (67858-693-04) 12 bottle2018-10-020000-00-00NoNoCurrent