Assured Instant Hand Sanitizer Refill 11.2oz

Product NDC
58503-122
Requested package NDC
58503-122-01
11-digit product format
585030122
Labeler code
58503
Product ID
58503-122_9db159b0-ee08-381d-e053-2a95a90a6360
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-02-03
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
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 packagepackage58503-12258503-122-01IInactivated 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
58503-122-012024-01-30C16284748780-11030e365-48b2-111a-e063-dadaa90a10e2Assured Instant Hand Sanitizer Refill 11.2 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-122-01Assured Instant Hand Sanitizer Refill 11.2ozAntimicrobial331 mL in 1 BOTTLEGEL3313

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-122ASSURED INSTANT HAND SANITIZER REFILL 11.2OZ ANTIMICROBIAL (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3Legacy NDC, 1 package rows20200204_9db159b0-ee13-381d-e053-2a95a90a6360.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN9db159b0-ee13-381d-e053-2a95a90a63603
581662ethanol 0.7 ML/ML Topical GelSCD9db159b0-ee13-381d-e053-2a95a90a63603
581662ethanol 70 % Topical GelSY9db159b0-ee13-381d-e053-2a95a90a63603
581662ethyl alcohol 70 % Topical GelSY9db159b0-ee13-381d-e053-2a95a90a63603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-122-0158503012201331 mL in 1 BOTTLE (58503-122-01) 331 ml2020-02-030000-00-00NoNoCurrent