FDA.reportPublic FDA data

DawnMist Alcohol Hand Sanitizer

Product NDC
65517-1007
Requested package NDC
65517-1007-3
11-digit product format
655171007
Labeler code
65517
Product ID
65517-1007_ea23e4b6-1d03-3dd9-e053-2a95a90a7911
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Dukal Corporation
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-01-14
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
700 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage65517-100765517-1007-3IInactivated by FDA2026-08-17

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 · 11 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…

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
65517-1007-1DawnMist Alcohol Hand Sanitizer
65517-1007-2DawnMist Alcohol Hand Sanitizer
65517-1007-3DawnMist Alcohol Hand Sanitizer
65517-1007-4DawnMist Alcohol Hand Sanitizer
65517-1007-5DawnMist Alcohol Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-1007-1DawnMist Alcohol Hand Sanitizer1.5 mL in 1 PACKETGEL1.57
65517-1007-2DawnMist Alcohol Hand Sanitizer59 mL in 1 BOTTLEGEL597
65517-1007-3DawnMist Alcohol Hand Sanitizer118 mL in 1 BOTTLEGEL1187
65517-1007-4DawnMist Alcohol Hand Sanitizer236 mL in 1 BOTTLEGEL2367
65517-1007-5DawnMist Alcohol Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2367

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MDAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
ALCOHOLACTIVE MOIETY3K9958V90MDAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
AMINOMETHYL PROPANEDIOLINACTIVE INGREDIENTCZ7BU4QZJZDAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWDAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8DAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RDAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-1007DAWNMIST ALCOHOL HAND SANITIZER (ALCOHOL) GEL [DUKAL LLC]7Legacy NDC, 5 package rows20231014_caa4c61d-efc6-41c6-bbef-de414d62ab10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNcaa4c61d-efc6-41c6-bbef-de414d62ab107
581662ethanol 0.7 ML/ML Topical GelSCDcaa4c61d-efc6-41c6-bbef-de414d62ab107
581662ethanol 70 % Topical GelSYcaa4c61d-efc6-41c6-bbef-de414d62ab107
581662ethyl alcohol 70 % Topical GelSYcaa4c61d-efc6-41c6-bbef-de414d62ab107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-1007-365517100703118 mL in 1 BOTTLE (65517-1007-3) 118 ml2013-01-140000-00-00NoNoCurrent