NO-WASH ANTIBACTERIAL

Product NDC
77331-001
11-digit product format
773310001
Labeler code
77331
Product ID
77331-001_63484d1d-53c2-46c4-b9fe-9dd23ccdbdb5
Type
HUMAN OTC DRUG
Nonproprietary name
ETHANOL
Dosage form
GEL
Route
TOPICAL
Labeler
MAJESTIC GROUP LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-06
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 · 15 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct77331-001IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-01IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-02IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-03IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-04IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-05IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-06IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-07IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-08IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-09IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-10IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-11IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-12IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-13IInactivated by FDA2026-10-15
excluded packagepackage77331-00177331-001-14IInactivated 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 5 · 270 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 packagepackage77331-001-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage77331-001-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage77331-001-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage77331-001-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage77331-001-05a1b67e2a42f9…c4cf2c586c0d…

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
77331-001-01NO-WASH ANTIBACTERIAL500 mL in 1 BOTTLEGEL5002
77331-001-02NO-WASH ANTIBACTERIAL20 mL in 1 BOTTLEGEL202
77331-001-03NO-WASH ANTIBACTERIAL30 mL in 1 BOTTLEGEL302
77331-001-04NO-WASH ANTIBACTERIAL40 mL in 1 BOTTLEGEL402
77331-001-05NO-WASH ANTIBACTERIAL50 mL in 1 BOTTLEGEL502
77331-001-06NO-WASH ANTIBACTERIAL60 mL in 1 BOTTLEGEL602
77331-001-07NO-WASH ANTIBACTERIAL80 mL in 1 BOTTLEGEL802
77331-001-08NO-WASH ANTIBACTERIAL100 mL in 1 BOTTLEGEL1002
77331-001-09NO-WASH ANTIBACTERIAL120 mL in 1 BOTTLEGEL1202
77331-001-10NO-WASH ANTIBACTERIAL250 mL in 1 BOTTLEGEL2502
77331-001-11NO-WASH ANTIBACTERIAL300 mL in 1 BOTTLEGEL3002
77331-001-12NO-WASH ANTIBACTERIAL1000 mL in 1 BOTTLEGEL10002
77331-001-13NO-WASH ANTIBACTERIAL2000 mL in 1 BOTTLEGEL20002
77331-001-14NO-WASH ANTIBACTERIAL5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77331-001NO-WASH ANTIBACTERIAL (ETHANOL) GEL [MAJESTIC GROUP LLC]2Legacy NDC, 14 package rows20200513_c47ddba9-9356-4225-a28b-69c5095006b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNc47ddba9-9356-4225-a28b-69c5095006b42
1305100ethanol 0.75 ML/ML Topical GelSCDc47ddba9-9356-4225-a28b-69c5095006b42
1305100ethanol 75 % Topical GelSYc47ddba9-9356-4225-a28b-69c5095006b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77331-001-0177331000101500 mL in 1 BOTTLE (77331-001-01) 500 ml2020-05-060000-00-00NoNoCurrent
77331-001-027733100010220 mL in 1 BOTTLE (77331-001-02) 20 ml2020-05-060000-00-00NoNoCurrent
77331-001-037733100010330 mL in 1 BOTTLE (77331-001-03) 30 ml2020-05-060000-00-00NoNoCurrent
77331-001-047733100010440 mL in 1 BOTTLE (77331-001-04) 40 ml2020-05-060000-00-00NoNoCurrent
77331-001-057733100010550 mL in 1 BOTTLE (77331-001-05) 50 ml2020-05-060000-00-00NoNoCurrent
77331-001-067733100010660 mL in 1 BOTTLE (77331-001-06) 60 ml2020-05-060000-00-00NoNoCurrent
77331-001-077733100010780 mL in 1 BOTTLE (77331-001-07) 80 ml2020-05-060000-00-00NoNoCurrent
77331-001-0877331000108100 mL in 1 BOTTLE (77331-001-08) 100 ml2020-05-060000-00-00NoNoCurrent
77331-001-0977331000109120 mL in 1 BOTTLE (77331-001-09) 120 ml2020-05-060000-00-00NoNoCurrent
77331-001-1077331000110250 mL in 1 BOTTLE (77331-001-10) 250 ml2020-05-060000-00-00NoNoCurrent
77331-001-1177331000111300 mL in 1 BOTTLE (77331-001-11) 300 ml2020-05-060000-00-00NoNoCurrent
77331-001-12773310001121000 mL in 1 BOTTLE (77331-001-12) 1000 ml2020-05-060000-00-00NoNoCurrent
77331-001-13773310001132000 mL in 1 BOTTLE (77331-001-13) 2000 ml2020-05-060000-00-00NoNoCurrent
77331-001-14773310001145000 mL in 1 BOTTLE (77331-001-14) 5000 ml2020-05-060000-00-00NoNoCurrent