FDA.reportPublic FDA data

HAND SANITIZER

Product NDC
75023-005
Requested package NDC
75023-005-04
11-digit product format
750230005
Labeler code
75023
Product ID
75023-005_ad192e16-71c0-7155-e053-2a95a90a57a4
Type
HUMAN OTC DRUG
Nonproprietary name
DENATURED DT ETHYL ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
SUN WAVE WELLNESS, LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-05
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 L/1.893L
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 packagepackage75023-00575023-005-04IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
75023-005-042022-01-28C16284748780-1d6a99b39-6085-a426-e053-dadaa90af4c2VERSION2: THIS IS INTENDED TO CORRECT AND REPLACE VERSION 1 OF SETID ITEM ENDING "...ADEE2" 2 CORRECTIONS: (1) TITLE (IE, THIS FIELD); (2) BACK LABEL: CONSUMER HAND SANITIZER; NON-EMERGENCY; SPECIALLY DENATURED ETHYL ALCOHOL = DEFERRED GRASE ACTIVE INGREDIENT DETERMINATION EFFECTIVE APRIL 13, 2020; PART333E FOR OTC HAND RUB SANITIZERS (CONSUMER)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75023-005-04HAND SANITIZER1.893 L in 1 BOTTLELIQUID1.8932

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75023-005HAND SANITIZER (DENATURED DT ETHYL ALCOHOL) LIQUID [SUN WAVE WELLNESS, LLC]2Legacy NDC, 1 package rows20200827_aa051319-09f1-57d5-e053-2a95a90adee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSNaa051319-09f1-57d5-e053-2a95a90adee22
582753ethanol 0.7 ML/ML Topical SolutionSCDaa051319-09f1-57d5-e053-2a95a90adee22
582753ethanol 70 % Topical SolutionSYaa051319-09f1-57d5-e053-2a95a90adee22
582753ethyl alcohol 70 % Topical SolutionSYaa051319-09f1-57d5-e053-2a95a90adee22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75023-005-04750230005041.893 L in 1 BOTTLE (75023-005-04) 1.893 l2020-07-050000-00-00NoNoCurrent