ACP Hand sanitizer

Product NDC
78287-160
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 · 12 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct78287-160IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-01IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-02IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-03IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-04IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-05IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-06IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-07IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-08IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-09IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-10IInactivated by FDA2026-08-17
excluded packagepackage78287-16078287-160-11IInactivated by FDA2026-08-17

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 4 · 216 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-160-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-160-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-160-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-160-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-11cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-160-07cfe11265f3b6…090c488252e2…

FDA-Initiated Inactive NDC Indexing#

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
78287-160-017828701600129 mL in 1 BOTTLE (78287-160-01) 29 ml2020-06-240000-00-00NoNoCurrent
78287-160-027828701600260 mL in 1 BOTTLE (78287-160-02) 60 ml2020-06-240000-00-00NoNoCurrent
78287-160-037828701600380 mL in 1 BOTTLE (78287-160-03) 80 ml2020-06-240000-00-00NoNoCurrent
78287-160-0478287016004100 mL in 1 BOTTLE (78287-160-04) 100 ml2020-06-240000-00-00NoNoCurrent
78287-160-0578287016005250 mL in 1 BOTTLE (78287-160-05) 250 ml2020-06-240000-00-00NoNoCurrent
78287-160-0678287016006260 mL in 1 BOTTLE (78287-160-06) 260 ml2020-06-240000-00-00NoNoCurrent
78287-160-0778287016007300 mL in 1 BOTTLE (78287-160-07) 300 ml2020-06-240000-00-00NoNoCurrent
78287-160-0878287016008500 mL in 1 BOTTLE (78287-160-08) 500 ml2020-06-240000-00-00NoNoCurrent
78287-160-0978287016009980 mL in 1 BOTTLE (78287-160-09) 980 ml2020-06-240000-00-00NoNoCurrent
78287-160-10782870160103785 mL in 1 BOTTLE (78287-160-10) 3785 ml2020-06-240000-00-00NoNoCurrent
78287-160-11782870160115000 mL in 1 CAN (78287-160-11) 5000 ml2020-06-240000-00-00NoNoCurrent