Prosilk hand Sanitizer

Product NDC
78242-001
Requested package NDC
78242-001-01
11-digit product format
782420001
Labeler code
78242
Product ID
78242-001_a62e6caa-6260-33f8-e053-2995a90a2d44
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-19
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage78242-00178242-001-01IInactivated by FDA2026-10-15

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 · 18 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
78242-001-012022-01-28C16284748780-1d6a99b39-f3df-a426-e053-dadaa90af4c2PROSILK Hand sanitizer Aloe vera
78242-001-022022-01-28C16284748780-1d6a99b39-f3df-a426-e053-dadaa90af4c2PROSILK Hand sanitizer Aloe vera

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78242-001-01Prosilk hand Sanitizer100 mL in 1 BOTTLEGEL1002
78242-001-02Prosilk hand Sanitizer250 mL in 1 BOTTLEGEL2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78242-001PROSILK HAND SANITIZER (ALCOHOL) GEL [DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 2 package rows20200522_4d1aa3e6-9da5-409d-888a-7792bb879728.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN4d1aa3e6-9da5-409d-888a-7792bb8797282
581662ethanol 0.7 ML/ML Topical GelSCD4d1aa3e6-9da5-409d-888a-7792bb8797282
581662ethanol 70 % Topical GelSY4d1aa3e6-9da5-409d-888a-7792bb8797282
581662ethyl alcohol 70 % Topical GelSY4d1aa3e6-9da5-409d-888a-7792bb8797282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78242-001-0178242000101100 mL in 1 BOTTLE (78242-001-01) 100 ml2020-03-190000-00-00NoNoCurrent