Zoviro

Product NDC
83814-001
11-digit product format
838140001
Labeler code
83814
Product ID
83814-001_31459c6a-45c2-bb69-e063-6294a90a58dc
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
Zoviro, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
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.13 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83814-001-01Zoviro3.136 g in 1 POUCHSWAB3.1362
83814-001-01Zoviro20 in 1 BAGSWAB202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83814-001ZOVIRO (BENZALKONIUM CHLORIDE) SWAB [ZOVIRO, LLC]2Current NDC, 2 package rows20250328_0b567ef2-a782-3daa-e063-6294a90a064e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN0b567ef2-a782-3daa-e063-6294a90a064e2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD0b567ef2-a782-3daa-e063-6294a90a064e2
1038558benzalkonium chloride 0.13 % Topical ClothSY0b567ef2-a782-3daa-e063-6294a90a064e2
1038558benzalkonium chloride 0.13 % Topical SwabSY0b567ef2-a782-3daa-e063-6294a90a064e2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY0b567ef2-a782-3daa-e063-6294a90a064e2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY0b567ef2-a782-3daa-e063-6294a90a064e2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY0b567ef2-a782-3daa-e063-6294a90a064e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83814-001-018381400010120 POUCH in 1 BAG (83814-001-01) / 3.136 g in 1 POUCH20 pouch2024-03-01NoNoHistorical