FDA.reportPublic FDA data

Servo Stat BAC

Product NDC
76378-023
Requested package NDC
76378-023-01
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038799Internal RxNorm lookup
1442964Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a5728eef-dd90-6d45-e053-2a95a90a31ceAvailable on FDA.report

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

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
Servo Stat BACBENZALKONIUM CHLORIDEEnzyme Solutions, Inc.a5728eef-dd90-6d45-e053-2a95a90a31ce2024-11-26WarningsExact identifier
ndc (package): 76378-023-01
ndc (product): 76378-023
ndc11 (package): 76378002301

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