FDA.reportPublic FDA data

UNICHEM

Product NDC
82150-570
Requested package NDC
82150-570-01
11-digit product format
821500570
Labeler code
82150
Product ID
82150-570_ef166616-6b54-3e05-e053-2a95a90acdfc
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer Refreshing Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Chemical Products, Corp.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-12-03
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
70 L/100L
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 packagepackage82150-57082150-570-01IInactivated 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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82150-570-012024-01-30C16284748780-11030e365-2273-111a-e063-dadaa90a10e2Hand Sanitizer Refreshing Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82150-570-01UNICHEM3.78 L in 1 BOTTLEGEL3.783

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82150-570UNICHEM (HAND SANITIZER REFRESHING GEL) GEL [UNIVERSAL CHEMICAL PRODUCTS, CORP.]3Legacy NDC, 1 package rows20221206_ca7a8e58-8ad0-005a-e053-2995a90ae9aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581698isopropyl alcohol 70 % Topical GelPSNca7a8e58-8ad0-005a-e053-2995a90ae9aa3
581698isopropyl alcohol 0.7 ML/ML Topical GelSCDca7a8e58-8ad0-005a-e053-2995a90ae9aa3
581698isopropyl alcohol 70 % Topical GelSYca7a8e58-8ad0-005a-e053-2995a90ae9aa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82150-570-01821500570013.78 L in 1 BOTTLE (82150-570-01) 3.78 l2020-12-030000-00-00NoNoCurrent