Hand Sanitizer

Product NDC
19392-130
11-digit product format
193920130
Labeler code
19392
Product ID
19392-130_d359e55c-ef5a-f0a6-e053-2995a90a84ac
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Bullet Line, LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-08
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
630 mL/1000mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct19392-130IInactivated by FDA2026-10-05
excluded packagepackage19392-13019392-130-01IInactivated 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 · 30 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 packagepackage19392-130-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage19392-130-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage19392-130-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage19392-130-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage19392-130-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage19392-130-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage19392-130-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage19392-130-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage19392-130-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage19392-130-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage19392-130-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage19392-130-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage19392-130-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage19392-130-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage19392-130-011332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
19392-130-012023-01-30C16284748780-19d75b9d0-6553-f424-e053-dadaa90a57ceDrug Facts
19392-130-012020-02-27C16284748780-19d75b9d0-6553-f424-e053-dadaa90a57ceDrug Facts
19392-130-012020-01-31C16284748780-19d75b9d0-6553-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
19392-130-01Hand Sanitizer8 mL in 1 BOTTLE, PLASTICLIQUID84

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]2
ALCOHOLACTIVE MOIETY3K9958V90MHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]2
BITTER ORANGE OILINACTIVE INGREDIENT9TLV70SV6IHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]2
WATERINACTIVE INGREDIENT059QF0KO0RHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
19392-130HAND SANITIZER (ALCOHOL) LIQUID [BULLET LINE, LLC]4Legacy NDC, 1 package rows20211218_1ceddc30-e41e-462c-89eb-afd0d004907c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041807alcohol 63 % Topical SolutionPSN1ceddc30-e41e-462c-89eb-afd0d004907c4
1041807ethanol 0.63 ML/ML Topical SolutionSCD1ceddc30-e41e-462c-89eb-afd0d004907c4
1041807ethanol 63 % Topical SolutionSY1ceddc30-e41e-462c-89eb-afd0d004907c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
19392-130-01193920130018 mL in 1 BOTTLE, PLASTIC (19392-130-01) 8 ml2014-10-080000-00-00NoNoCurrent