FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
19392-210
Requested package NDC
19392-210-07
11-digit product format
193920210
Labeler code
19392
Product ID
19392-210_d35a6841-3d38-b273-e053-2a95a90ad352
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
2010-01-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
620 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage19392-21019392-210-07IInactivated 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 · 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, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
19392-210-062023-01-30f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts
19392-210-072023-01-30f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts
19392-210-082023-01-30f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts
19392-210-092023-01-30f386c649-a28e-0266-e053-dadaa90a7c1aDrug Facts
19392-210-022019-11-1397449f38-b987-f6ea-e053-dbdaa90aa703Drug Facts
19392-210-032019-11-1397449f38-b987-f6ea-e053-dbdaa90aa703Drug Facts
19392-210-042019-11-1397449f38-b987-f6ea-e053-dbdaa90aa703Drug Facts
19392-210-052019-11-1397449f38-b987-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
19392-210-02Hand Sanitizer15 mL in 1 BOTTLE, PLASTICLIQUID155
19392-210-03Hand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID305
19392-210-04Hand Sanitizer44 mL in 1 BOTTLE, PLASTICLIQUID445
19392-210-05Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID605
19392-210-06Hand Sanitizer15 mL in 1 BOTTLE, PLASTICLIQUID154
19392-210-07Hand Sanitizer30 mL in 1 BOTTLE, PLASTICLIQUID304
19392-210-08Hand Sanitizer44 mL in 1 BOTTLE, PLASTICLIQUID444
19392-210-09Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID604

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]5
ALCOHOLACTIVE MOIETY3K9958V90MHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]5
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]5
EDETOLINACTIVE INGREDIENTQ4R969U9FRHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]5
WATERINACTIVE INGREDIENT059QF0KO0RHAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
19392-210HAND SANITIZER (ALCOHOL) LIQUID [HUMPHREYLINE]5Legacy NDC, 4 package rows20120803_7426b802-ff20-4e5e-a841-b104d1da031a.zip
19392-210HAND SANITIZER (ALCOHOL) LIQUID [BULLET LINE, LLC]4Legacy NDC, 4 package rows20211218_a61de07b-06c8-8edf-e053-2995a90af1c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
247835ethanol 62 % Topical SolutionPSN7426b802-ff20-4e5e-a841-b104d1da031a5
247835ethanol 0.62 ML/ML Topical SolutionSCD7426b802-ff20-4e5e-a841-b104d1da031a5
247835ethanol 62 % Topical SolutionSY7426b802-ff20-4e5e-a841-b104d1da031a5
247835ethyl alcohol 62 % Topical SolutionSY7426b802-ff20-4e5e-a841-b104d1da031a5
247835ethanol 62 % Topical SolutionPSNa61de07b-06c8-8edf-e053-2995a90af1c84
247835ethanol 0.62 ML/ML Topical SolutionSCDa61de07b-06c8-8edf-e053-2995a90af1c84
247835ethanol 62 % Topical SolutionSYa61de07b-06c8-8edf-e053-2995a90af1c84
247835ethyl alcohol 62 % Topical SolutionSYa61de07b-06c8-8edf-e053-2995a90af1c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
19392-210-071939202100730 mL in 1 BOTTLE, PLASTIC (19392-210-07) 30 ml2010-01-010000-00-00NoNoCurrent