FDA.reportPublic FDA data

Zoviro

Product NDC
83814-005
Requested package NDC
83814-005-01
11-digit product format
838140005
Labeler code
83814
Product ID
83814-005_40844d7d-3a4d-ce94-e063-6294a90a7fa7
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Zoviro, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-09
Substance
ALCOHOL
Active strength
70 mL/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
ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e85fb58-7cca-8ae3-e063-6294a90a2553Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83814-005-01Zoviro60 mL in 1 BOTTLELIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83814-005ZOVIRO (ALCOHOL) LIQUID [ZOVIRO, LLC]2Current NDC, 1 package rows20250205_0e85fb58-7cca-8ae3-e063-6294a90a2553.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
ZoviroALCOHOLZoviro, LLC0e85fb58-7cca-8ae3-e063-6294a90a25532025-10-06WarningsExact identifier
ndc (package): 83814-005-01
ndc (product): 83814-005
ndc11 (package): 83814000501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN0e85fb58-7cca-8ae3-e063-6294a90a25533
582753ethanol 0.7 ML/ML Topical SolutionSCD0e85fb58-7cca-8ae3-e063-6294a90a25533
582753ethanol 70 % Topical SolutionSY0e85fb58-7cca-8ae3-e063-6294a90a25533
582753ethyl alcohol 70 % Topical SolutionSY0e85fb58-7cca-8ae3-e063-6294a90a25533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83814-005-018381400050160 mL in 1 BOTTLE (83814-005-01) 60 ml2024-01-09NoNoCurrent