FDA.reportPublic FDA data

LATHER HAND SANITIZER

Product NDC
61577-1114
Requested package NDC
61577-1114-3
11-digit product format
615771114
Labeler code
61577
Product ID
61577-1114_fb046a9c-a143-47b3-92bc-c1e85f27f115
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-15
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
65 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 packagepackage61577-111461577-1114-3IInactivated by FDA2026-10-20

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 · 15 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…

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
61577-1114-2Lather Hand Sanitizer
61577-1114-3Lather Hand Sanitizer
61577-1114-4Lather Hand Sanitizer
61577-1114-6Lather Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1114-2LATHER HAND SANITIZER59 mL in 1 BOTTLE, PLASTICGEL591
61577-1114-3LATHER HAND SANITIZER296 mL in 1 BOTTLE, PUMPGEL2961
61577-1114-4LATHER HAND SANITIZER236 mL in 1 BOTTLE, PUMPGEL2361
61577-1114-6LATHER HAND SANITIZER473 mL in 1 BOTTLE, PUMPGEL4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1114LATHER HAND SANITIZER (ALCOHOL) GEL [SOMBRA COSMETICS]1Legacy NDC, 4 package rows20200722_e15b7e47-739a-45aa-a834-d1268a30b08b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSNe15b7e47-739a-45aa-a834-d1268a30b08b1
902574ethanol 0.65 ML/ML Topical GelSCDe15b7e47-739a-45aa-a834-d1268a30b08b1
902574ethyl alcohol 65 % Topical GelSYe15b7e47-739a-45aa-a834-d1268a30b08b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-1114-361577111403296 mL in 1 BOTTLE, PUMP (61577-1114-3) 296 ml2020-06-150000-00-00NoNoCurrent