Instant Hand Sanitizer Gel

Product NDC
78160-001
Requested package NDC
78160-001-25
11-digit product format
781600001
Labeler code
78160
Product ID
78160-001_a6a285de-bb1e-aa42-e053-2a95a90a1ce8
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Skinact
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 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 packagepackage78160-00178160-001-25IInactivated by FDA2026-10-05

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 · 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, Related label table
NDCRelated label
78160-001-01Instant Hand Sanitizer Gel
78160-001-02Instant Hand Sanitizer Gel
78160-001-03Instant Hand Sanitizer Gel
78160-001-04Instant Hand Sanitizer Gel
78160-001-05Instant Hand Sanitizer Gel
78160-001-06Instant Hand Sanitizer Gel
78160-001-07Instant Hand Sanitizer Gel
78160-001-08Instant Hand Sanitizer Gel
78160-001-09Instant Hand Sanitizer Gel
78160-001-10Instant Hand Sanitizer Gel
78160-001-11Instant Hand Sanitizer Gel
78160-001-12Instant Hand Sanitizer Gel
78160-001-13Instant Hand Sanitizer Gel
78160-001-14Instant Hand Sanitizer Gel
78160-001-15Instant Hand Sanitizer Gel
78160-001-16Instant Hand Sanitizer Gel
78160-001-17Instant Hand Sanitizer Gel
78160-001-18Instant Hand Sanitizer Gel
78160-001-19Instant Hand Sanitizer Gel
78160-001-20Instant Hand Sanitizer Gel
78160-001-21Instant Hand Sanitizer Gel
78160-001-22Instant Hand Sanitizer Gel
78160-001-23Instant Hand Sanitizer Gel
78160-001-24Instant Hand Sanitizer Gel
78160-001-25Instant Hand Sanitizer Gel
78160-001-26Instant Hand Sanitizer Gel
78160-001-27Instant Hand Sanitizer Gel
78160-001-28Instant Hand Sanitizer Gel
78160-001-29Instant Hand Sanitizer Gel
78160-001-30Instant Hand Sanitizer Gel
78160-001-31Instant Hand Sanitizer Gel
78160-001-32Instant Hand Sanitizer Gel
78160-001-33Instant Hand Sanitizer Gel
78160-001-34Instant Hand Sanitizer Gel
78160-001-35Instant Hand Sanitizer Gel
78160-001-36Instant Hand Sanitizer Gel
78160-001-37Instant Hand Sanitizer Gel
78160-001-38Instant Hand Sanitizer Gel
78160-001-39Instant Hand Sanitizer Gel
78160-001-40Instant Hand Sanitizer Gel
78160-001-41Instant Hand Sanitizer Gel
78160-001-42Instant Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78160-001-01Instant Hand Sanitizer Gel10 mL in 1 BOTTLEGEL101
78160-001-02Instant Hand Sanitizer Gel20 mL in 1 BOTTLEGEL201
78160-001-03Instant Hand Sanitizer Gel30 mL in 1 BOTTLEGEL301
78160-001-04Instant Hand Sanitizer Gel50 mL in 1 BOTTLEGEL501
78160-001-05Instant Hand Sanitizer Gel60 mL in 1 BOTTLEGEL601
78160-001-06Instant Hand Sanitizer Gel80 mL in 1 BOTTLEGEL801
78160-001-07Instant Hand Sanitizer Gel100 mL in 1 BOTTLEGEL1001
78160-001-08Instant Hand Sanitizer Gel150 mL in 1 BOTTLEGEL1501
78160-001-09Instant Hand Sanitizer Gel200 mL in 1 BOTTLEGEL2001
78160-001-10Instant Hand Sanitizer Gel30 mL in 1 BOTTLEGEL301
78160-001-11Instant Hand Sanitizer Gel50 mL in 1 BOTTLEGEL501
78160-001-12Instant Hand Sanitizer Gel60 mL in 1 BOTTLEGEL601
78160-001-13Instant Hand Sanitizer Gel80 mL in 1 BOTTLEGEL801
78160-001-14Instant Hand Sanitizer Gel100 mL in 1 BOTTLEGEL1001
78160-001-15Instant Hand Sanitizer Gel150 mL in 1 BOTTLEGEL1501
78160-001-16Instant Hand Sanitizer Gel200 mL in 1 BOTTLEGEL2001
78160-001-17Instant Hand Sanitizer Gel250 mL in 1 BOTTLEGEL2501
78160-001-18Instant Hand Sanitizer Gel240 mL in 1 BOTTLE, PUMPGEL2401
78160-001-19Instant Hand Sanitizer Gel240 mL in 1 BOTTLE, PUMPGEL2401
78160-001-20Instant Hand Sanitizer Gel250 mL in 1 BOTTLE, PUMPGEL2501
78160-001-21Instant Hand Sanitizer Gel300 mL in 1 BOTTLEGEL3001
78160-001-22Instant Hand Sanitizer Gel350 mL in 1 BOTTLE, PUMPGEL3501
78160-001-23Instant Hand Sanitizer Gel400 mL in 1 BOTTLE, PUMPGEL4001
78160-001-24Instant Hand Sanitizer Gel500 mL in 1 BOTTLE, PUMPGEL5001
78160-001-25Instant Hand Sanitizer Gel1000 mL in 1 BOTTLE, PUMPGEL10001
78160-001-26Instant Hand Sanitizer Gel2000 mL in 1 BOTTLE, PUMPGEL20001
78160-001-27Instant Hand Sanitizer Gel4000 mL in 1 BOTTLE, PUMPGEL40001
78160-001-28Instant Hand Sanitizer Gel5000 mL in 1 BOTTLE, PUMPGEL50001
78160-001-29Instant Hand Sanitizer Gel10000 mL in 1 BOTTLE, PUMPGEL100001
78160-001-30Instant Hand Sanitizer Gel15000 mL in 1 BOTTLE, PLASTICGEL150001
78160-001-31Instant Hand Sanitizer Gel20000 mL in 1 BOTTLE, PUMPGEL200001
78160-001-32Instant Hand Sanitizer Gel25000 mL in 1 BOTTLE, PUMPGEL250001
78160-001-33Instant Hand Sanitizer Gel50000 mL in 1 BOTTLE, PUMPGEL500001
78160-001-34Instant Hand Sanitizer Gel1000 mL in 1 BOTTLEGEL10001
78160-001-35Instant Hand Sanitizer Gel2000 mL in 1 BOTTLEGEL20001
78160-001-36Instant Hand Sanitizer Gel4000 mL in 1 BOTTLEGEL40001
78160-001-37Instant Hand Sanitizer Gel5000 mL in 1 BOTTLEGEL50001
78160-001-38Instant Hand Sanitizer Gel10000 mL in 1 BOTTLEGEL100001
78160-001-39Instant Hand Sanitizer Gel15000 mL in 1 BOTTLEGEL150001
78160-001-40Instant Hand Sanitizer Gel20000 mL in 1 BOTTLEGEL200001
78160-001-41Instant Hand Sanitizer Gel25000 mL in 1 BOTTLEGEL250001
78160-001-42Instant Hand Sanitizer Gel50000 mL in 1 BOTTLEGEL500001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78160-001INSTANT HAND SANITIZER GEL (ALCOHOL) GEL [SKINACT]1Legacy NDC, 42 package rows20200528_a6a2a334-df01-f1a5-e053-2995a90ab1cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa6a2a334-df01-f1a5-e053-2995a90ab1cd1
1305100ethanol 0.75 ML/ML Topical GelSCDa6a2a334-df01-f1a5-e053-2995a90ab1cd1
1305100ethanol 75 % Topical GelSYa6a2a334-df01-f1a5-e053-2995a90ab1cd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78160-001-25781600001251000 mL in 1 BOTTLE, PUMP (78160-001-25) 1000 ml2020-03-300000-00-00NoNoCurrent