Zoviro

Product NDC
83814-004
11-digit product format
838140004
Labeler code
83814
Product ID
83814-004_3bd195a9-39c8-0169-e063-6394a90afc29
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
2024-01-04
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
83814-004-01Zoviro80 in 1 BAGSWAB802
83814-004-01Zoviro3.136 g in 1 POUCHSWAB3.1362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83814-004ZOVIRO (BENZALKONIUM CHLORIDE) SWAB [ZOVIRO, LLC]1Current NDC, 2 package rows20240105_0e2b4917-0422-b320-e063-6394a90a731b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN0e2b4917-0422-b320-e063-6394a90a731b2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD0e2b4917-0422-b320-e063-6394a90a731b2
1038558benzalkonium chloride 0.13 % Topical ClothSY0e2b4917-0422-b320-e063-6394a90a731b2
1038558benzalkonium chloride 0.13 % Topical SwabSY0e2b4917-0422-b320-e063-6394a90a731b2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY0e2b4917-0422-b320-e063-6394a90a731b2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY0e2b4917-0422-b320-e063-6394a90a731b2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY0e2b4917-0422-b320-e063-6394a90a731b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83814-004-018381400040180 POUCH in 1 BAG (83814-004-01) / 3.136 g in 1 POUCH80 pouch2024-01-04NoNoHistorical