FDA.reportPublic FDA data

SEREN GUARD Sanitizing Wipes

Product NDC
79183-401
11-digit product format
791830401
Labeler code
79183
Product ID
79183-401_83373936-97ff-4ecb-96ac-282a243e0c6f
Type
HUMAN OTC DRUG
Nonproprietary name
Sanitizing Wipes
Dosage form
PATCH
Route
TOPICAL
Labeler
Prime Pace Products LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-30
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79183-401-082023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes
79183-401-162023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes
79183-401-202023-01-30C16284748780-1f386c649-d823-0266-e053-dadaa90a7c1aSEREN GUARD Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79183-401-08SEREN GUARD Sanitizing Wipes80 in 1 BOTTLE, DISPENSINGPATCH802
79183-401-08SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92
79183-401-16SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92
79183-401-16SEREN GUARD Sanitizing Wipes160 in 1 BOTTLE, DISPENSINGPATCH1602
79183-401-20SEREN GUARD Sanitizing Wipes200 in 1 BOTTLE, DISPENSINGPATCH2002
79183-401-20SEREN GUARD Sanitizing Wipes4.9 g in 1 PATCHPATCH4.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79183-401SEREN GUARD SANITIZING WIPES (SANITIZING WIPES) PATCH [PRIME PACE PRODUCTS LLC]2Legacy NDC, 6 package rows20201208_8595d28d-9870-4045-ad6b-aedefa6c93d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 % Topical ClothSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 % Topical SwabSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY8595d28d-9870-4045-ad6b-aedefa6c93d62
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY8595d28d-9870-4045-ad6b-aedefa6c93d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79183-401-087918304010880 PATCH in 1 BOTTLE, DISPENSING (79183-401-08) > 4.9 g in 1 PATCH80 patch2020-07-300000-00-00NoNoCurrent
79183-401-1679183040116160 PATCH in 1 BOTTLE, DISPENSING (79183-401-16) > 4.9 g in 1 PATCH160 patch2020-07-300000-00-00NoNoCurrent
79183-401-2079183040120200 PATCH in 1 BOTTLE, DISPENSING (79183-401-20) > 4.9 g in 1 PATCH200 patch2020-07-300000-00-00NoNoCurrent