FDA.reportPublic FDA data

Zoviro

Product NDC
83814-006
Requested package NDC
83814-006-01
11-digit product format
838140006
Labeler code
83814
Product ID
83814-006_40844d7d-3a50-ce94-e063-6294a90a7fa7
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Zoviro, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-21
Substance
BENZALKONIUM CHLORIDE
Active strength
.12 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.12 g/100mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046310Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33e1e96d-1058-35d5-e063-6394a90a4c9eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83814-006-01Zoviro281 mL in 1 BOTTLE, PUMPLIQUID2812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83814-006ZOVIRO (BENZALKONIUM CHLORIDE) LIQUID [ZOVIRO, LLC]1Current NDC, 1 package rows20250430_33e1e96d-1058-35d5-e063-6394a90a4c9e.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
ZoviroBENZALKONIUM CHLORIDEZoviro, LLC33e1e96d-1058-35d5-e063-6394a90a4c9e2025-10-06WarningsExact identifier
ndc (package): 83814-006-01
ndc (product): 83814-006
ndc11 (package): 83814000601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046310benzalkonium chloride 0.12 % Topical FoamPSN33e1e96d-1058-35d5-e063-6394a90a4c9e2
1046310benzalkonium chloride 1.2 MG/ML Topical FoamSCD33e1e96d-1058-35d5-e063-6394a90a4c9e2
1046310benzalkonium chloride 0.12 % Topical FoamSY33e1e96d-1058-35d5-e063-6394a90a4c9e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83814-006-0183814000601281 mL in 1 BOTTLE, PUMP (83814-006-01) 281 ml2025-04-21NoNoCurrent