FDA.reportPublic FDA data

germ-X Soft Wipes Alcohol Free Antibacterial

Product NDC
11344-801
Requested package NDC
11344-801-01
11-digit product format
113440801
Labeler code
11344
Product ID
11344-801_100ecbd6-4625-407d-8f17-62d90ed8b9e3
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride (0.13%)
Dosage form
CLOTH
Route
TOPICAL
Labeler
VI-JON
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-04-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 mg/100mg
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11344-80111344-801-01DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11344-801-012024-01-30C16284748780-11030e365-072f-111a-e063-dadaa90a10e2Germ-X Soft Wipes Alcohol Free Anitbacterial 40 Count
11344-801-022024-01-30C16284748780-11030e365-072f-111a-e063-dadaa90a10e2Germ-X Soft Wipes Alcohol Free Anitbacterial 40 Count
11344-801-032024-01-30C16284748780-11030e365-072f-111a-e063-dadaa90a10e2Germ-X Soft Wipes Alcohol Free Anitbacterial 40 Count

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7GERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0GERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8GERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51MGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
ETHYLPARABENINACTIVE INGREDIENT14255EXE39GERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5
WATERINACTIVE INGREDIENT059QF0KO0RGERM-X SOFT WIPES ALCOHOL FREE ANTIBACTERIAL (BENZALKONIUM CHLORIDE (0.13%)) CLOTH [VI-JON]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11344-801-011134408010130 mg in 1 POUCH (11344-801-01) 30 mg2005-04-010000-00-00NoNoCurrent