FDA.reportPublic FDA data

Servo-Stat

Product NDC
76378-015
11-digit product format
763780015
Labeler code
76378
Product ID
76378-015_27d5f33b-9c78-cfd7-e063-6394a90a453d
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Enzyme Solutions, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-01
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Servo-Stat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581660

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76378-015-01Servo-Stat118 mL in 1 BOTTLEGEL1184
76378-015-02Servo-Stat473 mL in 1 BOTTLEGEL4734
76378-015-03Servo-Stat946 mL in 1 BOTTLEGEL9464
76378-015-04Servo-Stat700 mL in 1 BAGGEL7004
76378-015-05Servo-Stat1000 mL in 1 BAGGEL10004
76378-015-06Servo-Stat59 mL in 1 BOTTLEGEL594

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MSERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1
ALCOHOLACTIVE MOIETY3K9958V90MSERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NSERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76378-015SERVO-STAT (ALCOHOL) GEL [ENZYME SOLUTIONS, INC.]4Current NDC, Legacy NDC, 6 package rows20241127_70562cae-b316-4033-b457-40ba71f6881c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN70562cae-b316-4033-b457-40ba71f6881c4
581660ethanol 0.62 ML/ML Topical GelSCD70562cae-b316-4033-b457-40ba71f6881c4
581660ethanol 62 % Topical GelSY70562cae-b316-4033-b457-40ba71f6881c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76378-015-0176378001501118 mL in 1 BOTTLE (76378-015-01) 118 ml2018-12-070000-00-00NoNoCurrent
76378-015-0276378001502473 mL in 1 BOTTLE (76378-015-02) 473 ml2018-12-070000-00-00NoNoCurrent
76378-015-0376378001503946 mL in 1 BOTTLE (76378-015-03) 946 ml2018-12-070000-00-00NoNoCurrent
76378-015-0476378001504700 mL in 1 BAG (76378-015-04) 700 ml2018-12-070000-00-00NoNoCurrent
76378-015-05763780015051000 mL in 1 BAG (76378-015-05) 1000 ml2018-12-070000-00-00NoNoCurrent
76378-015-067637800150659 mL in 1 BOTTLE (76378-015-06) 59 ml2011-02-01NoNoCurrent