FDA.reportPublic FDA data

Prosera Soothing Hand Sanitizer

Product NDC
75306-004
Requested package NDC
75306-004-06
11-digit product format
753060004
Labeler code
75306
Product ID
75306-004_cfd1205b-d005-0c3c-e053-2a95a90a4e12
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
D-Time Limited Liability Company
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-21
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 mL/100mL
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 packagepackage75306-00475306-004-06IInactivated by FDA2026-10-12

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
75306-004-01Prosera Soothing Hand Sanitizer
75306-004-02Prosera Soothing Hand Sanitizer
75306-004-03Prosera Soothing Hand Sanitizer
75306-004-04Prosera Soothing Hand Sanitizer
75306-004-05Prosera Soothing Hand Sanitizer
75306-004-06Prosera Soothing Hand Sanitizer
75306-004-07Prosera Soothing Hand Sanitizer
75306-004-08Prosera Soothing Hand Sanitizer
75306-004-09Prosera Soothing Hand Sanitizer
75306-004-10Prosera Soothing Hand Sanitizer
75306-004-11Prosera Soothing Hand Sanitizer
75306-004-12Prosera Soothing Hand Sanitizer
75306-004-13Prosera Soothing Hand Sanitizer
75306-004-14Prosera Soothing Hand Sanitizer
75306-004-15Prosera Soothing Hand Sanitizer
75306-004-16Prosera Soothing Hand Sanitizer
75306-004-17Prosera Soothing Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75306-004-01Prosera Soothing Hand Sanitizer30 mL in 1 BOTTLE, SPRAYLIQUID302
75306-004-02Prosera Soothing Hand Sanitizer50 mL in 1 BOTTLE, SPRAYLIQUID502
75306-004-03Prosera Soothing Hand Sanitizer60 mL in 1 BOTTLE, SPRAYLIQUID602
75306-004-04Prosera Soothing Hand Sanitizer100 mL in 1 BOTTLE, SPRAYLIQUID1002
75306-004-05Prosera Soothing Hand Sanitizer120 mL in 1 BOTTLE, SPRAYLIQUID1202
75306-004-06Prosera Soothing Hand Sanitizer150 mL in 1 BOTTLE, SPRAYLIQUID1502
75306-004-07Prosera Soothing Hand Sanitizer160 mL in 1 BOTTLE, SPRAYLIQUID1602
75306-004-08Prosera Soothing Hand Sanitizer200 mL in 1 BOTTLE, SPRAYLIQUID2002
75306-004-09Prosera Soothing Hand Sanitizer250 mL in 1 BOTTLE, SPRAYLIQUID2502
75306-004-10Prosera Soothing Hand Sanitizer500 mL in 1 BOTTLE, SPRAYLIQUID5002
75306-004-11Prosera Soothing Hand Sanitizer1000 mL in 1 BOTTLE, SPRAYLIQUID10002
75306-004-12Prosera Soothing Hand Sanitizer3785 mL in 1 BOTTLE, SPRAYLIQUID37852
75306-004-13Prosera Soothing Hand Sanitizer18927 mL in 1 BOTTLE, SPRAYLIQUID189272
75306-004-14Prosera Soothing Hand Sanitizer5000 mL in 1 BOTTLE, SPRAYLIQUID50002
75306-004-15Prosera Soothing Hand Sanitizer10000 mL in 1 BOTTLE, SPRAYLIQUID100002
75306-004-16Prosera Soothing Hand Sanitizer15000 mL in 1 BOTTLE, SPRAYLIQUID150002
75306-004-17Prosera Soothing Hand Sanitizer20000 mL in 1 BOTTLE, SPRAYLIQUID200002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75306-004PROSERA SOOTHING HAND SANITIZER (ALCOHOL) LIQUID [D-TIME LIMITED LIABILITY COMPANY]2Legacy NDC, 17 package rows20211103_67f9fb4c-b07a-4af0-a66e-24e34e16d7dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSN67f9fb4c-b07a-4af0-a66e-24e34e16d7dc2
1039339ethanol 0.8 ML/ML Topical SolutionSCD67f9fb4c-b07a-4af0-a66e-24e34e16d7dc2
1039339ethanol 80 % Topical SolutionSY67f9fb4c-b07a-4af0-a66e-24e34e16d7dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75306-004-0675306000406150 mL in 1 BOTTLE, SPRAY (75306-004-06) 150 ml2020-05-210000-00-00NoNoCurrent