FDA.reportPublic FDA data

Servo Stat BAC

Product NDC
76378-023
11-digit product format
763780023
Labeler code
76378
Product ID
76378-023_27d60ecd-338f-f00d-e063-6394a90ae607
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Enzyme Solutions, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-12
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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 BAC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038799, 1442964

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76378-023-01Servo Stat BAC473 mL in 1 BOTTLE, PLASTICLIQUID4732
76378-023-02Servo Stat BAC1000 mL in 1 BOTTLE, PLASTICLIQUID10002
76378-023-03Servo Stat BAC3785 mL in 1 BOTTLE, PLASTICLIQUID37852
76378-023-04Servo Stat BAC208175 mL in 1 DRUMLIQUID2081752
76378-023-05Servo Stat BAC1040875 mL in 1 TANKLIQUID10408752

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76378-023SERVO STAT BAC (BENZALKONIUM CHLORIDE) LIQUID [ENZYME SOLUTIONS, INC.]2Current NDC, Legacy NDC, 5 package rows20241127_a5728eef-dd90-6d45-e053-2a95a90a31ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSNa5728eef-dd90-6d45-e053-2a95a90a31ce2
1442964SERVO STAT BAC 0.1 % Topical FoamPSNa5728eef-dd90-6d45-e053-2a95a90a31ce2
1442964benzalkonium chloride 1 MG/ML Topical Foam [Servo Stat Bac]SBDa5728eef-dd90-6d45-e053-2a95a90a31ce2
1038799benzalkonium chloride 1 MG/ML Topical FoamSCDa5728eef-dd90-6d45-e053-2a95a90a31ce2
1038799benzalkonium chloride 0.1 % Topical FoamSYa5728eef-dd90-6d45-e053-2a95a90a31ce2
1442964Servo Stat Bac 0.1 % Topical FoamSYa5728eef-dd90-6d45-e053-2a95a90a31ce2
1442964Servo Stat Bac 1 MG/ML Topical FoamSYa5728eef-dd90-6d45-e053-2a95a90a31ce2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76378-023-0176378002301473 mL in 1 BOTTLE, PLASTIC (76378-023-01) 473 ml2020-05-120000-00-00NoNoCurrent
76378-023-02763780023021000 mL in 1 BOTTLE, PLASTIC (76378-023-02) 1000 ml2020-05-120000-00-00NoNoCurrent
76378-023-03763780023033785 mL in 1 BOTTLE, PLASTIC (76378-023-03) 3785 ml2020-05-120000-00-00NoNoCurrent
76378-023-0476378002304208175 mL in 1 DRUM (76378-023-04) 208175 ml2020-05-120000-00-00NoNoCurrent
76378-023-05763780023051040875 mL in 1 TANK (76378-023-05) 1040875 ml2020-05-120000-00-00NoNoCurrent