FDA.reportPublic FDA data

ACP Hand sanitizer

Product NDC
78287-160
Requested package NDC
78287-160-06
11-digit product format
782870160
Labeler code
78287
Product ID
78287-160_9af2a501-b2de-4c3e-8e70-489cc4df90dd
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Swanrose, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-24
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
73 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 packagepackage78287-16078287-160-06IInactivated 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
78287-160-01ACP Hand Sanitizer
78287-160-02ACP Hand Sanitizer
78287-160-03ACP Hand Sanitizer
78287-160-04ACP Hand Sanitizer
78287-160-05ACP Hand Sanitizer
78287-160-06ACP Hand Sanitizer
78287-160-07ACP Hand Sanitizer
78287-160-08ACP Hand Sanitizer
78287-160-09ACP Hand Sanitizer
78287-160-10ACP Hand Sanitizer
78287-160-11ACP Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78287-160-01ACP Hand sanitizer29 mL in 1 BOTTLEGEL291
78287-160-02ACP Hand sanitizer60 mL in 1 BOTTLEGEL601
78287-160-03ACP Hand sanitizer80 mL in 1 BOTTLEGEL801
78287-160-04ACP Hand sanitizer100 mL in 1 BOTTLEGEL1001
78287-160-05ACP Hand sanitizer250 mL in 1 BOTTLEGEL2501
78287-160-06ACP Hand sanitizer260 mL in 1 BOTTLEGEL2601
78287-160-07ACP Hand sanitizer300 mL in 1 BOTTLEGEL3001
78287-160-08ACP Hand sanitizer500 mL in 1 BOTTLEGEL5001
78287-160-09ACP Hand sanitizer980 mL in 1 BOTTLEGEL9801
78287-160-10ACP Hand sanitizer3785 mL in 1 BOTTLEGEL37851
78287-160-11ACP Hand sanitizer5000 mL in 1 CANGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78287-160ACP HAND SANITIZER (ETHYL ALCOHOL) GEL [SWANROSE, INC.]1Legacy NDC, 11 package rows20200710_38c62375-9d26-4de6-aeb4-f4177a7d662a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2286987ethanol 73 % Topical GelPSN38c62375-9d26-4de6-aeb4-f4177a7d662a1
2286987ethanol 0.73 ML/ML Topical GelSCD38c62375-9d26-4de6-aeb4-f4177a7d662a1
2286987ethanol 73 % Topical GelSY38c62375-9d26-4de6-aeb4-f4177a7d662a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78287-160-0678287016006260 mL in 1 BOTTLE (78287-160-06) 260 ml2020-06-240000-00-00NoNoCurrent