skin protectant

Product NDC
64092-383
Requested package NDC
64092-383-08
11-digit product format
640920383
Labeler code
64092
Product ID
64092-383_3b4b9696-8671-54a9-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Great lakes Wholesale, Marketing, and Sales, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-06-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
147 mL/237mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage64092-38364092-383-08IInactivated by FDA2026-10-15

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64092-383-082023-01-30C16284748780-1f386c649-c693-0266-e053-dadaa90a7c1a38b770e0-c0e0-4a26-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64092-383-08skin protectantSweet Pea237 mL in 1 BOTTLE, PUMPLIQUID2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64092-383SKIN PROTECTANT ORIGINAL (ALCOHOL) LIQUID SKIN PROTECTANT LAVENDER (ALCOHOL) LIQUID SKIN PROTECTANT ALOE VERA (ALCOHOL) LIQUID SKIN PROTECTANT SWEET PEA (ALCOHOL) LIQUID [GREAT LAKES WHOLESALE, MARKETING, AND SALES, INC.]2Legacy NDC, 1 package rows20160920_38b770e0-c0e0-4a26-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
247835ethanol 62 % Topical SolutionPSN38b770e0-c0e0-4a26-e054-00144ff88e882
247835ethanol 0.62 ML/ML Topical SolutionSCD38b770e0-c0e0-4a26-e054-00144ff88e882
247835ethanol 62 % Topical SolutionSY38b770e0-c0e0-4a26-e054-00144ff88e882
247835ethyl alcohol 62 % Topical SolutionSY38b770e0-c0e0-4a26-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64092-383-0864092038308237 mL in 1 BOTTLE, PUMP (64092-383-08) 237 ml2016-06-300000-00-00NoNoCurrent