FDA.reportPublic FDA data

Viroxyn Professional Use

Product NDC
66774-1003
11-digit product format
667741003
Labeler code
66774
Product ID
66774-1003_4fc1e4bd-01d8-4675-9e2e-a4ff884bda11
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride and Benzocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Quadex Pharmaceuticals LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-10-22
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
1 mg/mL; mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66774-1003-22019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use
66774-1003-32019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use
66774-1003-42019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use
66774-1003-52019-11-27C16284748780-19855d018-d6f4-cd31-e053-dbdaa90ab51aViroxyn ® Professional Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66774-1003-2Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-2Viroxyn Professional Use2 in 1 BLISTER PACKLIQUID21
66774-1003-3Viroxyn Professional Use3 in 1 BLISTER PACKLIQUID31
66774-1003-3Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-4Viroxyn Professional Use6 in 1 BOXLIQUID61
66774-1003-4Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-5Viroxyn Professional Use0.6 mL in 1 AMPULELIQUID0.61
66774-1003-5Viroxyn Professional Use12 in 1 BLISTER PACKLIQUID121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W7VIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1
BenzocaineACTIVE INGREDIENTU3RSY48JW5VIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1
BenzalkoniumACTIVE MOIETY7N6JUD5X6YVIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1
BenzocaineACTIVE MOIETYU3RSY48JW5VIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302VIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1
WaterINACTIVE INGREDIENT059QF0KO0RVIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66774-1003VIROXYN PROFESSIONAL USE (BENZALKONIUM CHLORIDE AND BENZOCAINE) LIQUID [QUADEX PHARMACEUTICALS LLC]1Legacy NDC, 8 package rows20121106_a7576e67-f1df-4653-a0bf-0495ec4883b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545787benzalkonium chloride 0.13 % / benzocaine 7.5 % Topical SolutionPSNa7576e67-f1df-4653-a0bf-0495ec4883b11
1545789benzalkonium chloride 1.3 MG/ML / benzocaine 75 MG/ML Topical Solution [Viroxyn]SBDa7576e67-f1df-4653-a0bf-0495ec4883b11
1545787benzalkonium chloride 1.3 MG/ML / benzocaine 75 MG/ML Topical SolutionSCDa7576e67-f1df-4653-a0bf-0495ec4883b11
1545787benzalkonium chloride 0.13 % / benzocaine 7.5 % Topical SolutionSYa7576e67-f1df-4653-a0bf-0495ec4883b11
1545789Viroxyn (benzalkonium chloride 0.13 % / benzocaine 7.5 % ) Topical SolutionSYa7576e67-f1df-4653-a0bf-0495ec4883b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66774-1003-2667741003020.6 mL in 1 AMPULE0.6 mlHistorical
66774-1003-3667741003033 in 1 BLISTER PACKHistorical
66774-1003-4667741003046 in 1 BOXHistorical
66774-1003-5667741003050.6 mL in 1 AMPULE0.6 mlHistorical