HUMASTE Hand Sanitizer

Product NDC
78287-130
11-digit product format
782870130
Labeler code
78287
Product ID
78287-130_246f191e-126d-4a5b-9c44-f1809c3221aa
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
2020-06-25
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 · 12 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct78287-130IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-01IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-02IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-03IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-04IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-05IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-06IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-07IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-08IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-09IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-10IInactivated by FDA2026-10-16
excluded packagepackage78287-13078287-130-11IInactivated by FDA2026-10-16

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 packagepackage78287-130-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78287-130-11d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78287-130-11f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage78287-130-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage78287-130-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-09cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage78287-130-11cfe11265f3b6…090c488252e2…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78287-130-01HUMASTE Hand Sanitizer50 mL in 1 BOTTLEGEL501
78287-130-02HUMASTE Hand Sanitizer60 mL in 1 BOTTLEGEL601
78287-130-03HUMASTE Hand Sanitizer100 mL in 1 BOTTLEGEL1001
78287-130-04HUMASTE Hand Sanitizer250 mL in 1 BOTTLEGEL2501
78287-130-05HUMASTE Hand Sanitizer300 mL in 1 BOTTLEGEL3001
78287-130-06HUMASTE Hand Sanitizer500 mL in 1 BOTTLEGEL5001
78287-130-07HUMASTE Hand Sanitizer560 mL in 1 BOTTLEGEL5601
78287-130-08HUMASTE Hand Sanitizer980 mL in 1 BOTTLEGEL9801
78287-130-09HUMASTE Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
78287-130-10HUMASTE Hand Sanitizer4000 mL in 1 BOTTLEGEL40001
78287-130-11HUMASTE Hand Sanitizer5000 mL in 1 CANGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78287-130HUMASTE HAND SANITIZER (ETHYL ALCOHOL) GEL [SWANROSE, INC.]1Legacy NDC, 11 package rows20200710_7ab6530a-4e1b-4080-84e5-a470d83a6d5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN7ab6530a-4e1b-4080-84e5-a470d83a6d5d1
581662ethanol 0.7 ML/ML Topical GelSCD7ab6530a-4e1b-4080-84e5-a470d83a6d5d1
581662ethanol 70 % Topical GelSY7ab6530a-4e1b-4080-84e5-a470d83a6d5d1
581662ethyl alcohol 70 % Topical GelSY7ab6530a-4e1b-4080-84e5-a470d83a6d5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78287-130-017828701300150 mL in 1 BOTTLE (78287-130-01) 50 ml2020-06-250000-00-00NoNoCurrent
78287-130-027828701300260 mL in 1 BOTTLE (78287-130-02) 60 ml2020-06-250000-00-00NoNoCurrent
78287-130-0378287013003100 mL in 1 BOTTLE (78287-130-03) 100 ml2020-06-250000-00-00NoNoCurrent
78287-130-0478287013004250 mL in 1 BOTTLE (78287-130-04) 250 ml2020-06-250000-00-00NoNoCurrent
78287-130-0578287013005300 mL in 1 BOTTLE (78287-130-05) 300 ml2020-06-250000-00-00NoNoCurrent
78287-130-0678287013006500 mL in 1 BOTTLE (78287-130-06) 500 ml2020-06-250000-00-00NoNoCurrent
78287-130-0778287013007560 mL in 1 BOTTLE (78287-130-07) 560 ml2020-06-250000-00-00NoNoCurrent
78287-130-0878287013008980 mL in 1 BOTTLE (78287-130-08) 980 ml2020-06-250000-00-00NoNoCurrent
78287-130-09782870130092000 mL in 1 BOTTLE (78287-130-09) 2000 ml2020-06-250000-00-00NoNoCurrent
78287-130-10782870130104000 mL in 1 BOTTLE (78287-130-10) 4000 ml2020-06-250000-00-00NoNoCurrent
78287-130-11782870130115000 mL in 1 CAN (78287-130-11) 5000 ml2020-06-250000-00-00NoNoCurrent